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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