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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How you can support progress in shoulder surgery

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Delayed onset of total shoulder pain and stiffness - suspect Propionibacterium

A 60 year old patient presented after a right total shoulder arthroplasty 20 years earlier. The shoulder had become progressively stiff and painful over the last several years. On examination his shoulder was stiff and painful.  There were no other clinical or laboratory suggestions of inflammation or infection. His SST was only 1/12. His radiographs showed some endosteal bone resorption near the distal end of his stem and some suggestion of thinning of the glenoid polyethlene.

 

At revision surgery the humeral component was somewhat loose, but the glenoid was secure, showing only minimal evidence of surface wear. There were no signs of joint fluid or inflammation within the joint. However, there was a thick leather-like humeral membrane, part of which is shown below.

The pathology on this membrane is shown below.

We performed a single stage exchange to a hemiarthroplasty, redraping and regowning after component removal and debridement and harvesting of five deep specimens for culture.

The new humeral stem was inserted using impaction allograft.

 

Because of our suspicion of infection - even though it had been 20 years since his index procedure, we started him on immediate Ceftriaxone and Vancomycin via a PICC line.

At 6 days after surgery, all of his cultures were positive for Propionibacterium

This case demonstrates the ability of Propionibacterium prosthetic shoulder infections to appear years after the index procedure without clinical or surgical evidence of infection. In male patients with delayed onset of pain and stiffness, we usually perform a single stage exchange to a hemiarthroplasty with a plan for IV antibiotics until the cultures are finalized at 3 weeks to make sure there is no gap in antibiotic coverage. If the cultures are positive, IV antibiotics are continued for 6 weeks followed by a 6 month course of oral antibiotics.

It is important to contrast this case with the following one:
Detritic synovitis can mimic a Propionibacterium periprosthetic infection

These authors illustrate that the clinical findings of detritic synovitis (the macrophage reaction to polyethylene, cement or metal debris) complicating a total shoulder arthroplasty can strongly resemble those of a ‘stealth’ periprosthetic shoulder infection with a low-virulence organism such as Propionibacterium, including a clinical presentation long after the index procedure. At present, the important differentiation between these two etiologies can only be ascertained by awaiting the results of cultures obtained at the time of revision surgery. The surgical and antibiotic treatment decisions must be made before the culture results become available.

Here is an informative case. A 76-year-old right hand dominant man presented with right shoulder pain and decreased range of motion. He had a history of bilateral total shoulder arthroplasties, his left 15 years prior and his right 14 years prior to his visit with us. Following his index surgeries he initially did well with full painless range of motion and was able to return to full activities. Eleven years after his right arthroplasty he experienced the insidious onset of worsening shoulder pain and stiffness with no known injury. He also noted painful catching and locking in his shoulder joint with certain shoulder movements. His symptoms were unresponsive to non-operative treatment, including exercises, anti-inflammatory medications and a corticosteroid injection. His left shoulder had some stiffness but was otherwise asymptomatic. The CBC, sedimentation rate and C-reactive protein were all normal.

Physical examination demonstrated a well-healed surgical scar with no erythema, drainage or evidence of infection. Both active and passive ranges of motion were decreased. There was palpable crepitus on range of motion. Rotator cuff strength was intact, as was neurologic function of the affected extremity. Radiographs demonstrated a thinned glenoid component with surrounding osteolysis, appearing grossly loose. The humeral component was well positioned with surrounding osteolysis of the medial and lateral proximal humeral bone. There were no radiolucencies around the distal stem and the prosthesis did not appear grossly loose.

                           

The patient was advised to have a revision shoulder arthroplasty to manage his symptoms and loose glenoid component. Because of the high index of suspicion of an infection, the plan included a one-stage revision to hemiarthroplasty followed by a course of intravenous antibiotic therapy until culture results were finalized. At the time of revision surgery, perioperative antibiotics were held until tissue cultures were obtained. There was abundant scar tissue surrounding the shoulder. A synovial fluid aspiration prior to capsulotomy showed grossly cloudy fluid with a negative gram stain, with no polymorphonuclear cells or organisms seen.  

There was diffuse membranous tissue around both the humeral and glenoid components.  There was osteolysis of the proximal humerus, but the humeral component was securely fixed ; it was removed without complication.  The glenoid component was grossly loose and easily removed.  There was significant wear of the glenoid polyethylene and osteolysis of the underlying glenoid bone.  The rotator cuff was intact.

A total of 8 samples for culture were taken from various locations within the glenohumeral joint, including the glenoid membrane, collar membrane between the modular humeral head and stem, humeral canal membrane, bursa, glenoid explant, and stem explant.  Due to preoperative and intraoperative concerns of infection, including cloudy fluid, abundant membrane, glenoid loosening and osteolysis, the patient was treated with a one-stage revision consisting of removal of the loose glenoid and single stage exchange of the humeral component using Vancomycin soaked cancellous allograft to secure the stem by impaction grafting.  The remaining glenoid bone was smoothed, no bone graft was added, and no glenoid component was reimplanted.  Cultures were grown on four types of media: blood agar, chocolate agar, Brucella agar and brain-heart infusion broth as previously published. Postoperatively the patient was placed on IV Ceftriaxone 2g daily and Vancomycin 1g daily via PICC line.  The Vancomycin was discontinued after 2 days when the cultures failed to grow MecA CoNS.  All cultures were negative at 21 days at which time all antibiotics were discontinued.  Permanent pathology of the deep tissues identified fibrotic tissue with chronic inflammation, the absence of neutrophils, and a foreign body giant cell reaction consistent with detritic synovitis

After surgery, he was placed on the standard post arthroplasty rehabilitation program focusing on range of motion in the first six weeks, followed by progressive anterior deltoid strengthening. At his six-month follow up visit, the patient was recovering well with no complaints of pain. His Simple Shoulder Test had improved from 5 out of 12 prior to his revision to 10 of 12, and radiographs showed a well-fixed humeral component.

  

Comment:  In this case, it seems unlikely that the cultures in this were falsely negative – multiple tissue and explant specimens were obtained before antibiotic administration, the specimens were cultured on multiple media and observed for 21 days. Thus, we must consider the possibility that the detritic synovitis from polyethylene debris produced osteolysis and periprosthetic membrane formation similar to that of a Propionibacterium infection. Until better methods become available for differentiating the two conditions, our practice is to continue to treat shoulders with osteolysis and glenoid component loosening as if they were infected until cultures prove this not to be the case.

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The reader may also be interested in these posts:

Healing through joint replacement

Supporting progress in shoulder surgery

Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book.

Click here to see the new Rotator Cuff Book

Information about shoulder exercises can be found at this link.

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

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

See from which cities our patients come.

See the countries from which our readers come on this post.

Failed reverse total shoulder arthroplasty - who's responsible?

Mechanics and complications of reverse shoulder arthroplasty: morse taper failure analysis and prospective rectification

These authors report a metallurgic analysis of the fractured humeral tray of a reverse total shoulder humeral component using Scanning Electron Microscopy (SEM) and Electron Dispersion Spectroscopy (EDS). The atraumatic failure occurred four years ofter the arthroplasty by dissociation of the taper from the humeral tray at the weld, leaving the Morse taper embedded in the humeral stem while the tray floated freely in the patient’s shoulder.

SEM further confirmed the jagged edges noted grossly at the weld fracture site, both suggesting failure due to torsional forces.

EDS detected elevated levels of carbon and oxygen at the fracture site on the taper. In order to determine the origin of the high levels of C and O, it was considered that in titanium alloys, C and O are used as stabilizers that help raise the temperature at which titanium can be cast. Since the presence of stabilizers reduces ductility and fatigue strength, all interstitial elements are removed after casting. Considering this, the presence of C and O suggests that not all of the interstitials were removed during the manufacturing process, resulting in decreased fatigue strength. In other words residual C and O in the taper lowered the metal implant’s integrity, leading to torsional cracking at the weld junction of the humeral tray and the taper. The elevated levels of C and O measured at fracture sites on both the tray and the taper suggest poor quality filler metal or failure to remove all interstitial elements after casting. The authors suggest that the system was undersized, considering the actions the shoulder is expected to be able to carry out. The short length of the Morse taper, thinness of the humeral tray, weaker metal system, and small surface area of the weld site between the taper and tray all posed probable causes of failure. The result was decreased fatigue strength and overall toughness, leading to mechanical failure.

This design has been recalled after a number of similar failures.

Comment: New shoulder implants are being introduced to the marketplace each year. Many of these have a modular design, which necessitates a junction between different component elements. Each of these junctions represents a site for potential corrosion and fatigue failure.

While it is tempting for surgeons to assume that "FDA approval" means that the device is safe, we must recognize that this approval usually does not include a careful trial of these implants in human subjects before they are released for general use. As a result, delayed failures - as represented by this report - may not become evident until after the implant has been out in general use for years. When design-related failures occur, years may pass before enough data are collected for a product recall.

Thus the surgeon needs to become a careful consumer, knowledgeable about metallurgy, fatigue and corrosion. 

A recent article discusses the surgeon's responsibility for the use of new technologies:

Introduction of New Technologies in Orthopaedic Surgery. 

The bullet points are

➢ The introduction of new devices, biologics, and combination products to the orthopaedic marketplace is increasing rapidly.

➢ The majority of these new technologies obtain clearance to market by demonstrating substantial equivalence to a predicate (previously approved device) according to the U.S. Food and Drug Administration (FDA) 510(k) process.

➢ Surgeons play a critical role in the introduction of new technologies to patients and must take a leadership role in promoting safe, efficacious, appropriate, and cost-effective care, especially for operative procedures.

➢ Surgeons should monitor and document their patients’ clinical outcomes and adverse events when using new technology, to ensure that the new technology is performing as desired.

This fits right in with a prior post: 

Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.

These authors note that there are two paths by which medical devices, such as shoulder implants, can obtain approval for use by the U.S. Food and Drug Administration (FDA).  The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be "substantially equivalent" to existing devices.

They hypothesized that because 510(k) approval was less stringent, it would be more commonly used on one hand and devices approved by this mechanism would be more likely to be recalled.

They searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties from 1992 to 2012. They also searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, they calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices.

While non-orthopaedic devices are increasingly approved by PMA:

Orthopaedic devices continue to be approved principally by 510(k):

The type of approval process is strongly related to the frequency of recall:from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. 

They conclude that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices; therefore is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data.

These data suggest that the 510(k) process, being easier and less expensive, is being used for devices that are not, in fact, "substantially equivalent to existing devices. " If they were "substantially equivalent", the recall rate discrepancy would not be what it is. It may be time to re-look at what it takes to qualify for 510(k) approval.

When we see data, such as that shown below from the AOA registry, it makes us wonder how "new" implants come to market, and which ones were claimed to be "substantially equivalent".

The question also arises, "with the dramatic increase in the number of new implants that are being introduced are patients getting better results?" See this recent post.

Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?

These authors noted that the number of shoulder arthroplasty implants and related devices approved by the FDA are improving exponentially with time.

These new devices increase the cost of shoulder arthroplasty surgery because of their associated development, FDA approval and marketing costs as well as the learning curves and uncertainty of outcomes in comparison to devices that have been in use for longer periods of time.

The authors sought to use published evidence from studies published from 1990 to 2015 to answer the question, "are the patient-reported outcomes and re-operation rates better in reports of more recently performed anatomic (TSA) and reverse (RSA) total shoulder arthroplasties?" The difficulty in answering such a question lies in the fact that the study methods and patient cohorts differ among different reports, confounding attempts to compare the results.

Inclusion criteria for this investigation were met by 42 TSA studies with a mean (± SD) of 116±159 (range, 20–705) patients per study with an average follow-up of 5±3 years, 42±21% males with average age 66±5 years. Inclusion criteria were met by 37 RSA studies with 56±32 (20–174) patients per study with an average follow-up of 4±5 years, 34±15% males with average age 72±5 years.

In order to compare studies that used different outcome scales (ASES, SST, Constant, Dash, SANE, etc), the authors normalized each scale to a 0 (worst) to 100 (best) outcome score.  They considered the outcome in terms of the final post-operative score as well as the percent of maximal possible improvement (%MPI).  As shown in the figure below, the particular outcome scale used in the different publications had a major effect on the normalized outcome score for shoulder arthroplasty. For TSA, the mean normalized post-operative scores were ≥80% for reports using the WOOS, UCLA, Penn, and SANE scales and <65% using the DASH or Constant scales. For RSA, the mean normalized postoperative scores were ≥70% for the Oxford, ASES and VAS Pain scales and ≤60% for the SANE and UCLA scales. For both TSA and RSA the Simple Shoulder Test was at the median.

The diagnosis for which the arthroplasty was performed presented another confounder in the comparison among studies.  For reports of TSA, osteoarthritis (OA) was most common diagnosis (73% for an average study), but the percentage of patients with this diagnosis varied greatly from study to study (0–100%). For reports of RSA, the most common diagnosis was cuff tear arthropathy (CTA) (48% for an average study) but, again, the percentage of patients with this diagnosis varied greatly from study to study (0-100%). For both types of arthroplasty, the diagnosis had a significant effect on the outcome as shown in the figure below. For TSA the results were worse in those studies of rheumatoid arthritis (RA) and cuff tear arthropathy (CTA). Clinical outcomes for RSA were worse in studies of post-traumatic arthritis (PTA).

Over the two decades of this study, there were marginally significantly better clinical outcomes in reports of more recently performed TSAs (p = 0.048). The plots below show the mean outcome score adjusted for outcome scale and diagnosis by median year of surgery.

For RSA the trend showed no significant improvement.

Neither the revision rate for TSA (Coefficient -0.48, 95% CI from -1.35 to 0.39, p= 0.3) or the revision rate for RSA (Coefficient -0.84, 95% CI (from -2.87 to 1.19, p= 0.4) were significantly lower in studies reporting more recently performed procedures.

It appears that better evidence will be necessary to demonstrate that newer implants and techniques are yielding improved clinical outcomes for patients with glenohumeral arthritis.

The authors suggest that future studies reporting the results of shoulder arthroplasty should include an appendix containing a set of basic data elements for each patient so that meaningful comparisons can be facilitated. Such a data set should include for each patient the age, sex, diagnosis, the scale used to document the presurgical and postoperative patient self-assessed shoulder comfort and function, and date and reason for any reoperation. While this minimal data set will not capture the full set of potential confounders— such as the degree of shoulder stiffness, the condition of the rotator cuff, radiographic pathoanatomy and the effect of surgical team volume and experience—this degree of standardization will enable a more robust comparison of the outcomes for individual patients treated over time with different therapeutic approaches, so that we can learn whether newer implants and techniques contribute added value to the patient with glenohumeral arthritis.

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Healing through joint replacement

Supporting progress in shoulder surgery

Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book

Click here to see the new Rotator Cuff Book

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

See from which cities our patients come.

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Acute failure of a hybrid glenoid component

Acute Failure of a Glenoid Component in Anatomic Shoulder Arthroplasty.


The authors remind us that glenoid loosening is the most common cause of failure in primary total shoulder arthroplasty and often occurs years after the initial surgery. In this case report, they present an unrecognized acute failure of a cemented hybrid glenoid component.

The patient was a 65-year-old man with persistent right shoulder pain and severely restricted range of motion approximately 10 months after a primary anatomic total shoulder performed for longstanding severe osteoarthritis with an intact cuff. The shoulder system was used for the index procedure included pegged, caged glenoid.

A CT arthrogram was ordered to evaluate if there was a rotator cuff tear but instead found that the glenoid component had dissociated and was sitting posterior to the humeral head .  The polyethylene glenoid component had disengaged from its metallic cage. One of the three metallic peg caps remained seated in the glenoid. 

Close inspection of the postoperative films, as early as those immediately following surgery in the postanesthesia care unit, confirmed that the glenoid had failed acutely.

At revision surgery, the glenoid component was retrieved from the posterior capsule. The component failure was seen to have occurred at the interface between one of the pegs and its metallic cap as well as at the cage component, which had disengaged from the polyethylene.

The authors point out that there have been prior recognized failures of this central cage locking mechanism. They suggest that this component requires “straight line” glenoid impaction, directly perpendicular to the face of the glenoid to prevent damage to the locking mechanism of the central peg as it engages the drilled hole. Failure to do so may disengage the central peg from the polyethylene.

Comment: This is points that each implant system has its particular features and that these need to be understood by the surgeon.

In our practice we use an all polyethylene component

our total shoulder arthroplasty is shown in this link.

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Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book.

Click here to see the new Rotator Cuff Book

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

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

See from which cities our patients come.

See the countries from which our readers come on this post.

Failed shoulder arthroplasty - the power of plain films

A man consulted with us recently about the sensation of clucking he has developed after a shoulder arthroplasty done elsewhere.

On examination a shift can be felt when he flexes his shoulder.

The two anteroposterior views are not that impressive.

However, the axillary view shows a large radiolucent zone between the cemented glenoid component and the glenoid bone. Thus suggests that the component is toggling on shoulder movement.

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Consultation for those who live a distance away from Seattle.

Click here to see the new Shoulder Arthritis Book

Click here to see the new Rotator Cuff Book

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

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

See from which cities our patients come.

See the countries from which our readers come on this post.

Reverse total shoulder components - the price of modularity

Fatigue failure of reverse shoulder humeral tray components of a single design

These authors suggest that modularity in reverse shoulder arthroplasty provides surgical flexibility and facilitates less-complex revision surgery, but that the potential for fatigue fracture is higher with modular components. 

They studied 8 humeral trays of nearly identical designs: 4 made of Ti-6Al-4V (Ti) and 4 made of CoCrMo (CoCr),

Both types of implant are still on the market.

Some of the results of this retrieval study are shown here.

As shown above, two Ti devices were revised for in vivo fracture.

Scanning electron microscopy showed cracking in the other 2 Ti trays and no evidence of cracking in the CoCr components. A geometric difference in the CoCr devices resulted in a 25% decreased stress under simulated activities of daily living. Accounting for the tray material properties, the fatigue failure envelope ranged from 1000 to 1 million cycles for Ti and from 30,000 to >10 million cycles for CoCr. Finite element and fatigue analyses predict a 10-fold lifetime increase for the CoCr devices compared with the Ti devices.

They concluded that fatigue failure is possible for some reverse shoulder components and is likely exacerbated by fillet radius, tray thickness, and material choice.

Comment: This report shows how important it is for the surgeon to understand the material and the geometry of the components he or she plans to use.

We've actually put up a post previously on this exact topic; it is reproduced below

Here's an instructive case that came to us for revision.

Three years ago a patient had a reverse total shoulder. Post operative films shown below

Within the first month the glenosphere dissociated from the baseplate requiring revision as shown below.

With a year or so, he developed pain and clunking in his shoulder and had these radiographic findings (problem is subtle, can you see it?)

 He came to see us at which time we obtained these films.

 Did you notice the dissociation of the humeral tray from the stem. It turns out that this tray was made of Titanium.

 In this cases, the stem of the tray had fatigued and fractured.

We were able to obtain a Chrome-Cobalt humeral tray and used it in our revision, shown below. We also resected the heterotopic bone and cultured the wound for Propionibacterium. There was no growth on these cultures.

In the current wave of enthusiasm for implanting reverse total shoulders, it is important to recognize that this is a technically demanding procedure and that each implant system has its own nuances for fixation of the glenoid base plate, glenosphere, humeral stem, humeral tray and humeral poly. This case also demonstrates that the forces at the articulation are large - enough to result in fatigue fracture of the stem of the tray. It also points out the importance of understand the metallurgy of the implant.

Our practice is to use an impaction grafted non-modular monoblock prosthesis , which avoids the risk of tray failure
                                                     

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Consultation for those who live a distance away from Seattle.

Check out the new Shoulder Arthritis Book - click here.

Click here to see the new Rotator Cuff Book

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

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

See from which cities our patients come.

See the countries from which our readers come on this post.