Reverse total shoulder - what's the news?

Unquestionably, the reverse total shoulder (rTSA) represents a major technological advance for the treatment of patients with complex shoulder disorders.  The number of reverse total shoulders implanted in patients is growing rapidly due to (1) more surgeons using it, (2) its use in both older and young patients, and (3) its use to treat an expanding number of shoulder conditions.

Below are some comments on recent articles relevant to the rTSA.

FDA clearnance

The reverse total shoulder was first cleared for use in the United States by the Federal Drug Administration (FDA) twenty years ago. The FDA has the authority for approving use of orthopaedic implants by the 510(k) "clearance" mechanism, which bypasses the clinical trials required by the PreMarket Approval pathway which is used to assure the safety and efficacy of new medications (see How effective is the U.S. Food and Drug Administration (FDA) in assuring safety and effectiveness of shoulder arthroplasty implants? ).

Note below that the decision for 510(k) clearance of the reverse total shoulder was based on the device being "substantially equivalent" to a device previously cleared by the FDA. 

While the anatomic total shoulder had been previously cleared by the FDA for use in the United States; there was no "substantially equivalent" reverse total shoulder that was "previously cleared" for use in the U.S. (most surgeons and patients would not conclude that the reverse total shoulder (below left) is "substantially equivalent" to the anatomic total shoulder (below right)).

A recent article authored by eight leading U.S. shoulder surgeons, Off-label use of reverse total shoulder arthroplasty: the American Academy of Orthopedic Surgeons Shoulder and Elbow Registry, observed that the FDA originally cleared the "on label" use of the rTSA for "grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint." They also pointed out that surgeons now use rTSA for "many off-label indications: osteoarthritis (OA) without rotator cuff tear (RCT), massive RCT without OA, proximal humerus fractures (PHFx), inflammatory arthritis (IA), and chronic glenohumeral joint dislocation (GHJD)".

They analyzed 3850 rTSA procedures reported to the AAOS registry from January 2015 to March 2021 "Only 24.4% of rTSA surgeries were performed for original on-label use (rotator cuff tear arthropathy). Off-label use of rTSA was seen in 75.6% of cases. When reviewing those rTSA done off-label, the majority (41.4%) were done for OA without RCT. Other off-label rTSA use included 15.1% for RCT without OA, 13% potentially off-label for PHFx, 4.6% for IA, and 1.6% for GHJD. Proportionally, off-label use is increasing over time while on-label use is decreasing." 

These authors concluded that "Some implant manufacturers have expanded indications for rTSA without providing clinical data to support changing FDA approved indications for use. The incremental expansion of indications for use without supportive data - a practice known as predicate creep - is occurring with rTSA. Performing rTSA for off-label indications may create liability risk for surgeons and implant manufacturers. Device manufacturers should formally expand indications of use for rTSA with the FDA to be consistent with published literature and trends."

Indications

A common rationale for the use of the rTSA is pseudoparalysis - the inability of the shoulder to actively elevate the arm (see Pseudoparalysis in massive irreparable rotator cuff tears: what is it and why is it so important?). Shoulders without pseudoparalysis are often well treated with an anatomic shoulder arthroplasty, but those with pseudoparalysis are not (see What if the patient with an irreparable cuff tear and arthritis doesn't want a reverse total shoulder?).

With the expansion of indications for rTSA, it is apparent that a large percentage of patients receiving rTSA do not have pseudoparalysis. For example in Impact of accumulating risk factors on the acromial and scapular fracture rate after reverse total shoulder arthroplasty with a medialized glenoid-lateralized humerus onlay prosthesis, the preoperative active elevation for the 138 patients having postoperative scapular or acromial fractures complicating rTSA averaged 83.2 ± 41.8. A normal (bell-shaped) distribution of these values suggests that almost half of these patients may not have had preoperative pseudoparalysis.

Prosthesis design and position.

In a study comparing 27 patients with a lateralized glenosphere and 26 patients with a nonlateralized and distalized glenosphere, Clinical and radiological outcomes in lateralized versus nonlateralized and distalized glenospheres in reverse total shoulder arthroplasty: a randomized control trial, there were no significant differences between the groups in the two-year clinical outcomes.

In Neck shaft angle in reverse shoulder arthroplasty: 135 vs. 145 degrees at minimum 2-year follow-up there were no significant differences in clinical or functional outcomes.

As suggested by these articles, the outcome of rTSA may be dependent on factors other than prosthesis geometry and implantation technique.

You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link.

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Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
How to x-ray the shoulder (see this link).
The ream and run procedure (see this link).
The total shoulder arthroplasty (see this link).
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link).
Shoulder rehabilitation exercises (see this link).

Reverse total shoulder arthroplasty - is its current use consistent with FDA's "Indications for Use"?

The Federal Drug Administration (FDA) oversees the approval of new drugs and devices for use on patients in the United States, defines the Indications for Use, and then labels the product with those indications. 

The FDA cleared the first reverse total shoulder arthroplasty (rTSA) for use in the United States in late 2003 (Delta Shoulder K021478; DePuy Inc., Raynham, MA, USA). The FDA approved on-label Indications for Use for rTSA at that time were limited to cuff tear arthropathy and revision surgery: “Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device" (see shoulder prosthesis, reverse configuration and FDA clearance).

After the clearance for rTSA use for rotator cuff tear arthropathy, surgeons began to use rTSA for off-label indications (i.e. those other than the original approved indications), such as osteoarthritis without rotator cuff tear, massive cuff tear without osteoarthritis, proximal humerus fractures, tumor, inflammatory arthritis, and chronic glenohumeral joint dislocation. Since 2006,  some devices were subsequently cleared by the FDA for use in proximal humeral fractures and other indications; on the other hand, some reverse shoulder devices remain cleared only for the initial indications. 

The authors of Off Label use of Reverse Total Shoulder Arthroplasty: The American Academy of Orthopedic Surgeons Shoulder and Elbow Registry evaluated the trends for the rTSA in the United States with respect to those uses that were consistent with the original FDA approval and those which were "off label". They analyzed 3850  rTSA procedures reported to the AAOS shoulder and elbow registry from Jan 2015-Mar 2021.

 
They found that only 24.4% of rTSA surgeries were performed for original on-label use (rotator cuff tear arthropathy). Off-label use of rTSA was seen in 75.6% of cases. Furthermore, they found that off-label use is increasing over time while on-label use is decreasing.

When reviewing those rTSA done off-label, the majority (41.4%) were done for osteoarthritis without cuff tear. Other off-label rTSA use included 15.1% for cuff tear without arthritis, 13% potentially off-label for proximal humeral fractures, 4.6% for inflammatory arthropathy and 1.6% for glenohumeral dislocation. 

The authors point out that "some implant manufacturers have expanded indications for rTSA without providing clinical data to support changing FDA approved Indications for Use. They presented the table below showing the approved and unapproved indications for different implants.

"Only 10-15% of the 510(k) premarket notification applications are supported by clinical data. The incremental expansion of Indications for Use without supportive data, a practice known as predicate creep, is occurring with rTSA. Performing rTSA for off-label indications may create liability risk for surgeons and implant manufacturers.".

The FDA does allow for some off-label use of devices stating: “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects”

Despite the leeway the FDA provides in permitting surgeons to use devices off-label under practice of medicine, surgeons in the United States may still be at risk for litigation when using rTSA for an off-label indication, particularly if they have a financial relationship with the company or other conflict of interest, or the informed consent does not document that the off label use of the device was discussed with the patient.

Comment: These authors conclude that the current Indications for Use of rTSA are confusing and not uniform among systems. They recommend that device manufacturers pursue labelling changes by the FDA supported by the clinical data needed to formally expand these indications.

See this related post discussing off-label use: Reverse total shoulder arthroplasty: trends and complications in ABOS board candidates

You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link.

Follow on twitter: https://twitter.com/shoulderarth

Follow on facebook: click on this link

Follow on facebook: https://www.facebook.com/frederick.matsen

Follow on LinkedIn: https://www.linkedin.com/in/rick-matsen-88b1a8133/

Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
How to x-ray the shoulder (see this link).
The ream and run procedure (see this link).
The total shoulder arthroplasty (see this link).
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link).
Shoulder rehabilitation exercises (see this link).

How effective is the U.S. Food and Drug Administration (FDA) in assuring safety and effectiveness of shoulder arthroplasty implants?

New joint replacement systems and implants are cleared for clinical use by the Food and Drug Administration (FDA) by what is known as the 510(k) mechanism.

510(k) clearance does not require testing of safety and efficacy in clinical trials (see Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis). Instead 510(k) clearance requires evidence of “substantial equivalence” to a predicate device, i.e. one that has previously been cleared by the FDA. 

Companies use the 510(k) premarket notification pathway for expedient approval of arthroplasty. With the passage of the 21st Century Cures Act, a piece of legislation reducing the rigor and amount of clinical testing required before device clearance, the 510(k) pathway has became further streamlined.

The number of shoulder implants approved by the 510(k) process is rising exponentially (see Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?)



No fewer than twenty-nine new shoulder devices having received 510(k) premarket FDA approval over the 12-month period from 2020 – 2021.

Unfortunately, devices cleared through the 510(k) process are 11.5 times more likely to be recalled than devices approved via the more stringent Premarket Approval (PMA) process (see Analysis of FDA-Approved Orthopaedic Devices and Their Recalls). PMA approval is based on a determination by FDA that there is sufficient valid scientific evidence based on formal clinical trials to assure that the device is safe and effective.

Recalls of devices cleared by the 510(k) process typically occur years after the introduction of the device to clinical practice and after hundreds or thousands have been implanted into patients. Consider, for example, the ASR Acetabular & Resurfacing System which was recalled 6 years after being introduced into the market, after 90,000 had been implanted, and after 30% had been revised (see Out of joint: The story of the ASR).

Similarly, for three elbow implants, the lag between introduction to the market and recall ranged from 4 to 16 years, even though there were earlier reports of failure in the FDA's Manufacturer and User Facility Device Experience (MAUDE) data base (see Timely recognition of total elbow and radial head arthroplasty adverse events: an analysis of reports to the US Food and Drug Administration and Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016)





The authors of Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis sought to evaluate the FDA clearance of shoulder arthroplasty components by examining the interconnected ancestral network of shoulder arthroplasty devices and determining equivalency ties to devices that were subsequently recalled by the FDA because of design-related issues of relevance to patient safety.

They reviewed the FDA 510(k) database to identify all legally marketed shoulder arthroplasty devices from 5/28/1976 to 7/1/2021. Direct predicate information obtained via clearance summary documents associated with each device was used to generate an ancestral genealogy network for all shoulder arthroplasty devices cleared between 7/1/2020 and 7/1/2021. FDA design recalls were analyzed, and the number of descendent devices was calculated for each recalled device.

Their evaluation of all 476 shoulder devices cleared since 1976 identified between 0 and 313 descendent devices for each.

Of the 476 FDA cleared shoulder arthroplasty devices, 130 (27.3%) were linked to at least one predicate device that was subsequently recalled for issues with device design. Furthermore among 29 of the most-recently cleared devices (7/1/2020 – 7/1/2021), 16 (55.2%) were linked to predicate devices that have subsequently been withdrawn from the market due to design related failures. During this time interval no devices were cleared by the more vigorous PMA pathway.

80 of the devices (16.8%) cleared by the 510(k) pathway have since been recalled, of which 10 recalls were directly related to implant design issues (5 shoulder implant systems, 4 humeral components, and 1 glenoid component.) Of the ten devices recalled for device design, the most influential by number of ancestral descendants was K052906 (Zimmer Trabecular Metal Reverse Shoulder System) that had served as an ancestral predicate for 110 descendent devices.

One of the devices, (K080642 - Biomet Comprehensive Reverse Shoulder) was cleared by the FDA in 2008 and recalled in August 2017 due to higher than anticipated rates of implant breakage. K080642 - Biomet Comprehensive Reverse Shoulder served as an ancestral predicate for 67 descendant devices as shown in the figure below which indicates all descendants (Key: Red = recalled, yellow = direct predicate was recalled, green = not recalled and does not have a direct predicate that was recalled).



In 2011, the Institute of Medicine held a workshop that recommended replacement of the 510(k)-clearance process and implement in its place a regulatory premarket and postmarket regulatory framework to provide “a reasonable assurance of safety and effectiveness throughout the device life cycle.” In Congress, legislation to amend the 510(k)- approval process – the Safety of Untested and New Devices Act of 2012 – was introduced but failed to receive a vote on the floor.

Questions regarding the effectiveness of the FDA clearance process for orthopaedic devices have surfaced in the lay press. In 2018 the New York Times published, Can Your Hip Replacement Kill You?
This article tells the story of how orthopaedic implants can get 'cleared' by the FDA for use in patients without rigorous studies of their safety or effectiveness. The author states that the public "assumes that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all."

Orthopaedic surgeons should read the related book from cover to cover:

Comment: As orthopaedic surgeons, we are frequently presented with new implants that have just arrived on the marketplace, most of which have been 'cleared' by the 510(k) process because they are stated to be 'substantially equivalent' to a previously marketed device. However, these new devices cannot be 'completely equivalent' to implants that are currently available (otherwise they could not be patented and successfully marketed). The gap between 'substantial' and 'complete' equivalency allows for unexpected results and unanticipated complications as well as new technical challenges and learning curves in using the new system. Thus, when considering a new device, we need to ask "in what ways is the new thing different than what is currently in common use?" and "what are the potential adverse outcomes that might result from these differences" (see Assessing the Value to the Patient of New Technologies in Anatomic Total Shoulder Arthroplasty).

Finally, it seems that we should push for a better definition of "substantial equivalency'. Different bearing surfaces, different articular surface shapes, different materials, different fixation systems, and different degrees of modularity do not seem to be 'substantially equivalent'. Patient safety would seem to be served by a closer examination of systems that are not, in fact, substantially equivalent.

See this related post on device failure and FDA clearance.

You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link.

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Follow on twitter: https://twitter.com/shoulderarth

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Follow on facebook: https://www.facebook.com/frederick.matsen

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Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The ream and run procedure (see this link).

The total shoulder arthroplasty (see this link).

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

High complication and revision rates for an "innovation" in upper extremity arthroplasty - does the FDA protect us?

Total elbow arthroplasty is used to manage elbow arthritis and fractures. In contrast to the normal elbow joint - where stability is provided by collateral ligaments and compression of the humeral trochlea into the concavity of the proximal ulna - total elbow designs commonly provide stability using a hinge connecting stemmed humeral and ulnar components, a configuration that is often needed because the normal ligamentous stability has been compromised by arthritis or fracture. An example is the Coonrad/Morrey Total Elbow.

One of the issues with using a hinge for stability is that substantial torque is applied to the prosthesis challenging the cement fixation of the stems.  Achieving durably secure fixation is difficult, as a result component loosening is not uncommon.  Yet another issue is the susceptibility of the polyethylene bushings to wear with subsequent instability and the risk of osteolysis. Periprosthetic fractures can result from the combination of an unyielding hinge and weakened bone. Another is the problem of abutment of the coronoid process against the distal humeral implant as shown below. 

In Experience with the Coonrad-Morrey total elbow arthroplasty: 78 consecutive total elbow arthroplasties reviewed with an average 5 years of follow-up the authors reported that at an average of 5 years of follow-up (2 to 11 years), radiolucencies were observed in 17 cases around the humeral component and in 14 cases around the ulnar component. Bushing wear was observed in 14 cases. There were 27 complications, and 9 of them went to a revision procedure. The survival rate was 97.7% at 5 years and 91.0% at 10 years if one considers revision for aseptic loosening as an endpoint.

In an attempt to improve these outcomes, the Nexel Total Elbow (see this link) was introduced with an "innovative 3rd bearing in the humeral yoke for increased compressive contact area" and "a robust Co-Cr linkage system to enhance linkage durability"

The manufacturer reported a predicted revision rate per 100 observed component years (OCY) of 4.2 for this implant (see this link).

However, at the March, 2022 meeting of the American Academy of Orthopaedic surgeons, a paper by Jacob Triplet, Mark Morrey, Shawn O'Driscoll, Joaquin Sanchez-Sotelo, and Chad Songy entitled Unexpected High Early Failure Rate of the Nexel Total Elbow Arthroplasty reported a 50% reoperation rate. The abstract is reproduced here.

"INTRODUCTION: Aseptic loosening, polyethylene wear and other forms of mechanical failure have limited the use of total elbow arthroplasty (TEA) in physically demanding patients. Newer implant designs have been introduced to improve mechanical performance; however, there is limited information about their clinical outcomes. The purpose of this study was to report the results obtained after implantation of a newer TEA design, the Nexel (Zimmer-Biomet, Warsaw, IN) TEA. METHODS: Over a 3-year period, two surgeons implanted a total of 35 consecutive Nexel primary TEAs. Average patient age was 65 (range, 29-95) years. Indications for TEA included failed open reduction and internal fixation or posttraumatic arthritis (17 elbows), acute distal humerus fracture (9 elbows), and inflammatory arthritis (9 elbows). Elbows were evaluated for pain, motion, the Mayo Elbow Performance Score (MEPS), complications, and reoperations
RESULTS: Of the thirty-five elbows, 12 (34%) underwent revision surgery with removal of either part or all Nexel components, with an average time to revision surgery of 2.2 years. Eleven of the 12 revision surgeries were performed at our Institution. All these eleven elbows were found to have gross loosening of one or both components at the time of revision surgery (9 loose humeral and 6 loose ulnar components). Forty-five percent had evidence of metallic debris within the bushing. Six of the 12 elbows revised were also noted to present with a periprosthetic fracture (5 humeral and 2 ulnar periprosthetic fractures). Of the remaining elbows, 2 were lost to follow-up, 18 had at least 2-year clinical follow-up, and 14 had 2-year minimum radiographic follow up. For patients with surviving implants, the mean follow-up time was 1.7 years. Radiographic evaluation of existing components revealed humeral component loosening in two elbows and periprosthetic fractures in four elbows (2 medial epicondyle, 1 olecranon, 1 humeral shaft). Overall, 17/35 (50%) elbows underwent reoperation and 20/35 (60%) elbows sustained at least one postoperative complication.
DISCUSSION AND CONCLUSION:
Primary TEA with implantation of this particular implant was associated with an unacceptably high rate of early implant loosening, periprosthetic fracture and reoperation. We hypothesize that this early unexpected mechanical failure could be explained by both the utilization of a titanium on polyethylene bearing surface as well as a more posterior center of rotation causing premature anterior impingement with flexion, which in turn leads to failure of the bonding interface, secondary titanium particle shedding, polyethylene wear and osteolysis."

Interestingly, an article published a year earlier, Short-term outcomes of the Nexel total elbow arthroplasty reported a two-year complication rate of 56% and a 22% revision rate. Aseptic humeral loosening was the main indication for revision. 

Comment:  From these two studies the short term outcomes for the innovative Nexel implant appear inferior to the long term outcomes of the Coonrad-Morrey implant.  One might ask, "does the FDA protect patients from devices with higher failure rates?". In that light, it is illuminating to review the FDA clearance for this innovation (see this link).

510 (k) Summary of Safety and Effectiveness - Zimmer Nexel Total Elbow

Comparison to Predicate Device: The Zimmer Nexel Total Elbow is substantially equivalent to the predicate device in terms of form and function. The Zimmer Nexel Total Elbow and the predicate device share similar intended uses and indications for use.

Comparison to the Predicate: The proposed device (Zimmer Nexel Total Elbow) and the predicate device (Coonrad/Morrey Total Elbow) have the same intended use and similar indications for use. The proposed device humneral and ulnar components are very similar in terms of materials used and design/dimensions to the predicate device humneral and ulnar components. The primary differences between the proposed and predicate devices are that the proposed device bearing components-are made of Vitamin E highly cross-linked polyethylene (the predicate device bearing components are made of ultra-high molecular-weight polyethylene), and the proposed device has bearings that articulate on both the outer and inner diameters of the ulnar eye (the predicate device has bearings that articulate on the inner diameter of the ulnar eye). Additionally, the proposed device uses screws and a I-part axle pin to fix the bearings in place, while the predicate device uses a 2-part (snap-fit) axle pin.

Performance Data:Non-Clinical Performance Testing Conducted:

• -  Stem Fatigue Testing

• -  Wear Testing

• -  Durability Testing

• -  Modular Connection Fatigue testing

  Non-Clinical Performance Testing Conclusions:

  Non-clinical testing demonstrated that the New Zimmer Total Elbow meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.

  *In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.

One might ask "if  the device is "substantially equivalent" to the Coonrad-Morrey, why does the failure rate appear to be substantially higher?"

For more information about what the FDA does and does not do to protect patients and surgeons, see this link. 

The  US Food and Drug Administration maintains the Manufacturer and User Facility Device Experience (MAUDE). The MAUDE database is a publicly funded and publicly available means by which surgeons can identify adverse events for the prostheses they use before such information becomes available through journal publication or recall notification. This database has been the source for a recent article Timely recognition of total elbow and radial head arthroplasty adverse events: an analysis of reports to the US Food and Drug Administration which found that among 179 total elbow adverse event reports, the most common modes of failure were implant dissociation (23%), loosening (22%), and infection (16%). Three implant recalls were implemented 2, 5, and 9 years after the first adverse event report in the MAUDE database. Thus the MAUDE database provides alerts on prostheses that may be subsequently recalled 

The MAUDE data on over 100 adverse events associated with the Nexel implant are shown in this link, examples are shown on the list below.

Clicking on each these reports opens a report such as the below - some revealing as yet unpublished modes of failure.

This whole story gives us a lot to think about - most importantly how we do we consider the safety, value, and effectiveness of "innovations" over and against our standard accepted approaches for our patients.

You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link.

Follow on twitter: https://twitter.com/shoulderarth

Follow on facebook: click on this link

Follow on facebook: https://www.facebook.com/frederick.matsen

Follow on LinkedIn: https://www.linkedin.com/in/rick-matsen-88b1a8133/

Here are some videos that are of shoulder interest

Shoulder arthritis - what you need to know (see this link).

How to x-ray the shoulder (see this link).

The ream and run procedure (see this link).

The total shoulder arthroplasty (see this link).

The cuff tear arthropathy arthroplasty (see this link).

The reverse total shoulder arthroplasty (see this link).

The smooth and move procedure for irreparable rotator cuff tears (see this link).

Shoulder rehabilitation exercises (see this link).

Shoulder joint replacement failure - a bigger problem than previously recognized.

Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016

Most of the literature on shoulder arthroplasty failure comes from high-volume centers. These reports tend to exclude the experience of community orthopedic surgeons, who perform most of the shoulder joint replacements.

These authors analyzed the failure reports mandated by the US Food and Drug Administration for all hospitals. Each reported event from 2012 to 2016 was characterized by implant, failure mode, and year of surgery.

For the 1673 anatomic arthroplasties, the most common failure modes were glenoid component failure (20.4%), rotator cuff/subscapularis tear (15.4%), pain/stiffness (12.9%), dislocation/instability (11.8%), infection (9%), and humeral component loosening (5.1%). 

For anatomic shoulder arthroplasties, the failure modes have not appreciably changed over recent years

For the 2390 reverse arthroplasties, the most common failure modes were dislocation/instability (32%), infection (13.8%), glenosphere-baseplate dissociation (12.2%), failed/loosened baseplate (10.4%), humeral component dissociation/tray fracture (5.5%), difficulty inserting the baseplate (4.8%), and difficulty inserting the glenosphere (4.2%). 

For reverse shoulder arthroplasties, the failure modes have not appreciably changed over recent years

Although the percentage distribution among the different failure modes was relatively consistent over the years of this study, the percentage distribution of these failure modes differed substantially among different implant manufacturers.

The authors conclude that the Food and Drug Administration database reveals modes of shoulder arthroplasty failurethat are not emphasized in the published literature, such as rotator cuff tear, infection, and postoperative pain/stiffness for anatomic total shoulder arthroplasty and implant dissociation and baseplate failure for reverse shoulder arthroplasty. Knowledge of these failure modes may help inform surgical technique and implant design in ways that will lower the risk of implant failure in the future.

Comment: In addition to the high numbers of failures reported to the FDA, the authors note that the rate of recall of new devices is also high, possibly due to unanticipated modes of failure that become evident only after periods of use. 

It is important to recognize that the device failures reported to the FDA under represents the number of actual arthroplasty device failures because there is no method for assuring that each device failure is reported.

The high rate of failure of new devices suggests caution before the adoption of new implants and instruments. Surgeons should recognize that 510(k) clearance requires only that the manufacturer demonstrate that the new device is "substantially equivalent" to a previously marketed device (even if the the previously marketed device has been recalled). This is in marked contrast to the rigorous premarket approval process the FDA requires for new drugs - the PMA process requires demonstration of both safety and efficacy.

We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art"  regarding this radically conservative approach to shoulder arthritis at this link and this link

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Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages   arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'

4063 complications of shoulder arthroplasty - what the literature doesn't tell us

Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016

These authors point out that most of the literature on shoulder arthroplasty failure comes from high-volume centers and that these reports tend to exclude the experience of community orthopedic surgeons, who perform most of the shoulder joint replacements.

They analyzed the failure reports mandated by the US Food and Drug Administration for all hospitals. Each reported event from 2012 to 2016 was characterized by implant, failure mode, and year of surgery.

Although the percentage distribution among the different failure modes was relatively consistent over the years of this study, the percentage distribution of these failure modes differed substantially among different implant manufacturers.

For the 1673 anatomic arthroplasties, the most common failure modes were glenoid component failure (20.4%), rotator cuff/subscapularis tear (15.4%), pain/stiffness (12.9%), dislocation/instability (11.8%), infection (9%), and humeral component loosening (5.1%).

For the 2390 reverse arthroplasties, the most common failure modes were dislocation/instability (32%), infection (13.8%), glenosphere-baseplate dissociation (12.2%), failed/loosened baseplate (10.4%), humeral component dissociation/tray fracture (5.5%), difficulty inserting the baseplate (4.8%), and difficulty inserting the glenosphere (4.2%).

The percentage distribution of the failure modes also differed substantially from those published in a recent review of the literature.

They concluded that the publicly available Food and Drug Administration database reveals modes of shoulder arthroplasty failure that are not emphasized in the published literature, such as rotator cuff tear, infection, and postoperative pain/stiffness for anatomic total shoulder arthroplasty and implant dissociation and baseplate failure for reverse shoulder arthroplasty.

Comment: This study points to the utility of the freely accessible FDA MAUDE database as a resource for identifying failure modes for shoulder arthroplasty not readily identified in the published literature. Some modes of failure appear in the MAUDE data base long before they appear in the published literature, such as the dissociation of the glenosphere from the the baseplate as shown below.

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We have a new set of shoulder youtubes about the shoulder, check them out at this link.

Be sure to visit "Ream and Run - the state of the art"  regarding this radically conservative approach to shoulder arthritis at this link and this link

Use the "Search" box to the right to find other topics of interest to you.

How you can support progress in shoulder surgery

You may be interested in some of our most visited web pages   arthritis, total shoulder, ream and run, reverse total shoulder, CTA arthroplasty, and rotator cuff surgery as well as the 'ream and run essentials'