Arthrex® AR-9501-13SRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS APEX STEM, SIZE 13 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867250543), received between Oct 17, 2022 and Oct 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN A PATIENT UNDERWENT A REVERSE MODULAR SHOULDER PROCEDURE ON (B)(6) 2020. DURING THIS PROCEDURE AN AR-9501-13S APEX HUMERAL STEM, AN AR-9502F-39LCPC SUTURE CUP, AN AR-9503M-03 HUMERAL INSERT, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AN AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE, WERE SUCCESSFULLY IMPLANTED. TWO YEARS LATER, ON (B)(6) 2022, PATIENT UNDERWENT A REVISION REVERSE TOTAL SHOULDER PROCEDURE BECAUSE THE CENTRAL AND PERIPHERAL SCREWS BROKE OFF THE BASEPLATE.
Patient problems: Failure of Implant
MAUDE report 15615005 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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