Arthrex® AR-9504S-INFRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS GLENOSPHERE 36 +2.5 INF · 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 00888867061415), received between Apr 4, 2019 and Apr 4, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A TOTAL REVERSE SHOULDER PROCEDURE ON (B)(6) 2018 DURING WHICH THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-9502F-36RCPC (LOT 170027905); AR-9502F-36CPC (LOT 170018606); AR-9501-06P (LOT 170088903); AR-9503S-03 (170085610); AR-9504S-INF (LOT 160071710); AR-9120-01 (LOT 170115115); AR-9165-20 (LOT 170056412); AR-9145-24 (LOT 170101712). PATIENT ALSO UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DURING WHICH THE AR-9503S-03 WAS EXPLANTED AND AN AR-9503S-06 (LOT 170150113)WAS IMPLANTED. THE REVISION SURGERY IS BEING REPORTED UNDER CASE (B)(4). PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION. THE INFECTION IS BEING REPORTED UNDER THE FOLLOWING: (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8483560 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page