Arthrex® AR-9503XS-06Recalls & reported problems
Arthrex, Inc. · Humeral Insert XS 33+6mm · 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 00888867406858), received between Mar 27, 2025 and Mar 27, 2025 — 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
- 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.
InjuryMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ADDITIONAL INFORMATION RECEIVED ON 3/24/025: AR-9564-2433-LAT ARTHREX UNIVERS REVERS GLENOSPHERE WERE EXPLANTED AS WELL. AR-9503-3336-3 UNIVERS REVERS COMBO HUMERAL INSERT WAS ATTEMPTED TO BE USED WITH THE SPACER, BUT IT WOULD NOT FIT, SO THE SURGEON TURNED TO AN AR-9503-3336-6C UNIVERS REVERS MODULAR GLENOID SYSTEM, CONSTRAINED COMBO HUMERAL INSERT. IT WAS ALSO REPORTED THAT THE SCREW FROM THE INITIAL AR-9504-06 UNIVERS REVERS SPACER WAS NOT WORKING AND AN AR-9502RSC UNIVERS REVERS REPLACEMENT CUP SCREW HAD TO BE USED.
Patient problems: Failure of Implant
MAUDE report 21708415 ↗
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- 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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