Arthrex® AR-9502-42RCPCRecalls & reported problems
Arthrex, Inc. · UNIVERS REVS CUP,42/+ 2MM RT OFFSET CTD · Class 2 · Implant
Data updated Oct 16, 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 00888867061200), received between Nov 1, 2016 and Nov 1, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2016Material Twisted/Bent
IT WAS REPORTED THAT A MALE PATIENT HAD UNDERGONE A RIGHT REVERSE TOTAL SHOULDER PROCEDURE APPROXIMATELY TWO YEARS PRIOR IN ANOTHER STATE. ON (B)(6) 2016 PATIENT WAS UNDERGOING A PROCEDURE TO REMOVE THE PRIOR IMPLANTS DUE TO INFECTION. DURING THE PROCEDURE SURGEON WAS USING THE AR-8943-10, T15 HEXALOBE SCREWDRIVER (B)(6) AND THE THREADS TWISTED MAKING IT NO LONGER USABLE. THEN THE SURGEON USED THE AR-9202-T15H, UNIVERSAL GLENOID T15 LONG DRIVER (B)(6) AND FOUND THE THREADS TWISTED RENDERING IT UNUSABLE. THESE DEVICES ARE FROM LOANER SET RAR-9501GS #14. NO PATIENT INJURY REPORTED. THE CASE WAS COMPLETED USING HOSPITAL OWNED SPARE SCREWDRIVERS WHICH WERE ALSO IN BAD CONDITION. INFORMATION OBTAINED 10/13/2016: PRIOR TO THE REVISION PROCEDURE PATIENT HAD A NORMAL BLOODWORK IN 2014, ASPIRATION OF 45CC IN (B)(6) 2016 AND POSITIVE TEST FOR PROPION BACTERIUM ACNES. AT THE TIME OF THE REVISION AN EXTENDED HOLD CULTURE WAS DONE AND READ ON (B)(6) 2016 AS WELL AS (B)(6) 2016 AND IS CURRENTLY ONGOING. NO AEROBES ISOLATED OR ANEROBIC GROWTH OF BACTERIA FOUND. NO EVIDENCE OF MALIGNANCY. THE FOLLOWING PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 (B)(6), AR-9502-42RCPC (B)(6), A
Patient problems: Unspecified Infection
MAUDE report 6068918 ↗
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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