Arthrex® AR-9501-09SRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS APEX STEM, SIZE 9 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867250505), received between Jul 25, 2024 and Jul 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 7/9/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS. IMAGES WERE TAKEN ON (B)(6) 2024, SHOWING THE PATIENT NO LONGER HAD THE ORIGINAL ARTHREX IMPLANTS FROM THE ORIGINAL SURGERY ON (B)(6) 2022. UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED ON (B)(6) 2022 AT AN OUTSIDE FACILITY. AN AR-9501-09S UNIVERS REVERS APEX HUMERAL STEM SIZE 9, AN AR-9502F-36RCPC ARTHREX UNIVERS REVERS SUTURE CUP 36 MM, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE 20 MM, AN AR-9580-2420-2 UNIVERS REVERS MODULAR GLENOID SYSTEM, AUGMENTED BASEPLATE 24 MM +2, 20 DEGREE FULL, TWO AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9503-3633-3C UNIVERS REVERS MODULAR GLENOID SYSTEM CONSTRAINED COMBO HUMERAL INSERT 36 +3C / 33, AN AR-9564-2433 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE 33/24, AND TWO AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 24 MM, WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION OTHER THAN THE DATE OF SURGERY WAS AVAILABLE
Patient problems: Insufficient Information
MAUDE report 19829598 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page