Arthrex® AR-9505-15Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS SPACER 39+15MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061453), received between Dec 2, 2020 and Feb 6, 2025 — classified as 2 injuries.
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
- Appropriate Device Problem Term/Code Not Available1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT MULTIPLE SURGERIES ON THE REPORTED SHOULDER PROSTHESIS. IT WAS FURTHER REPORTED THAT SOME REVISION SURGERIES HAVE BEEN PERFORMED. IT WAS FURTHER REPORTED THAT THE CUSTOMER HAS IN ADDITION TO THE REPORTED DEVICES FIVE SCREWS (1 SILVER, 3 GREEN, 1 PURPLE), A BASE PLATE, GLENOSPHERE, AN INLAY AND A POST.
Patient problems: Failure of Implant
MAUDE report 21323191 ↗InjuryDec 2, 2020Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT COMPLICATION OCCURRED THAT WAS POSSIBLY RELATED TO AN ARTHEX PRODUCT. UPON FURTHER INVESTIGATION THE FOLLOWING WAS DISCOVERED: PATIENT UNDERWENT AN (B)(6) 2019 SHOULDER PROCEDURE. THE PATIENT HAD A POST-OPERATIVE DISLOCATION RESULTING IN A (B)(6) 2019 REVISION SURGERY. DURING THE REVISION PROCEDURE THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9503M-03C /HUMERAL INSERT AND AR-9505-15 /UNIVERS REVERSE SPACER. TO COMPLETE THE REVISION PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING TWO ARTHREX DEVICES: AR-9503M-06 /HUMERAL INSERT AND AR-9505-15 /UNIVERS REVERSE SPACER.
Patient problems: Joint Dislocation
MAUDE report 10934417 ↗
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.
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