Somerson, J Shoulder Elbow Surg 2018 - Analysis of 4063 Complications of Shoulder Arthroplasty Reported to the US Food and Drug Administration from 2012 to 2016

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Analysis of 4063 Complications of Shoulder Arthroplasty Reported to the US Food and Drug Administration from 2012 to 2016

Somerson, Matsen, et al.·J Shoulder Elbow Surg·2018·127 citations

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Somerson and colleagues used the FDA's mandatory device‑failure database to describe how anatomic and reverse shoulder arthroplasties fail nationwide, over time and by manufacturer.

Retrospective review of 4063 unique MAUDE reports from 2012 to 2016: 1673 anatomic and 2390 reverse arthroplasties.

Key Findings

In anatomic arthroplasty, glenoid component failure led the reports at 341 of 1673 (20.4%), ahead of cuff or subscapularis failure (257, 15.4%) and pain/stiffness (215, 12.9%).
In reverse arthroplasty, dislocation/instability was the leading mode at 764 of 2390 (32.0%), followed by infection at 330 (13.8%).
Component dissociation and baseplate failure made up a large share of reverse reports: glenosphere‑baseplate dissociation 292 (12.2%), failed or loosened baseplate 248 (10.4%) and humeral dissociation or tray fracture 132 (5.5%).
Compared with a cited review of published series (Bohsali), cuff tears (15.4% vs 9.0%) and infections (9.0% vs 4.9%) made up a larger share of anatomic reports here, and glenoid failure a smaller share (20.4% vs 60.3%).
Across the years analyzed, the shares of the 6 most common anatomic modes varied by 7% or less, and those of the 7 most common reverse modes by 10% or less.
Among the 10 manufacturers with at least 20 reports, glenoid failure ranged from 5% to 43% of a company's anatomic reports and dislocation from 7% to 44% of its reverse reports.

Authors' conclusion

The 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. 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.

Analysis of 4063 Complications of Shoulder Arthroplasty Reported to the US Food and Drug Administration from 2012 to 2016.

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Analysis of 4063 Complications of Shoulder Arthroplasty Reported to the US Food and Drug Administration from 2012 to 2016

Somerson, Matsen, et al.·J Shoulder Elbow Surg·2018·127 citations

|||

Somerson and colleagues used the FDA's mandatory device‑failure database to describe how anatomic and reverse shoulder arthroplasties fail nationwide, over time and by manufacturer.

Retrospective review of 4063 unique MAUDE reports from 2012 to 2016: 1673 anatomic and 2390 reverse arthroplasties.

Key Findings

In anatomic arthroplasty, glenoid component failure led the reports at 341 of 1673 (20.4%), ahead of cuff or subscapularis failure (257, 15.4%) and pain/stiffness (215, 12.9%).
In reverse arthroplasty, dislocation/instability was the leading mode at 764 of 2390 (32.0%), followed by infection at 330 (13.8%).
Component dissociation and baseplate failure made up a large share of reverse reports: glenosphere‑baseplate dissociation 292 (12.2%), failed or loosened baseplate 248 (10.4%) and humeral dissociation or tray fracture 132 (5.5%).
Compared with a cited review of published series (Bohsali), cuff tears (15.4% vs 9.0%) and infections (9.0% vs 4.9%) made up a larger share of anatomic reports here, and glenoid failure a smaller share (20.4% vs 60.3%).
Across the years analyzed, the shares of the 6 most common anatomic modes varied by 7% or less, and those of the 7 most common reverse modes by 10% or less.
Among the 10 manufacturers with at least 20 reports, glenoid failure ranged from 5% to 43% of a company's anatomic reports and dislocation from 7% to 44% of its reverse reports.

Authors' conclusion

The 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. 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.

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