Arthrex® AR-9504LRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS GLENO 42 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061330), received between Feb 20, 2018 and Mar 14, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Detachment Of Device Component1
- Loss of Osseointegration1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PROSTHESIS HAD TO BE REMOVED AFTER 5 YEARS AS THE GLENOID SPHERE BECAME LOOSENED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 11-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT ONLY THE GLENOSPHERE BECAME LOOSENED. THE PLATE AND SCREWS DID NOT HAVE ANY ISSUES BUT WERE REPLACED DURING THE REVISION INCLUDING THE INLAY AND THE GLENOSPHERE.
Patient problems: Failure of Implant
MAUDE report 18905868 ↗InjuryOct 18, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. . NO FURTHER INFORMATION RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 17958975 ↗InjuryFeb 20, 2018Detachment Of Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RTSA PROCEDURE ON (B)(6) 2017. THE SALES REP WAS INFORMED THAT THE RTSA WAS GOING TO BE REVISED BY A SURGEON DIFFERENT FROM THE ORIGINAL SURGEON FOR DISASSOCIATION OF THE GLENOSPHERE. ARTHREX REP SPOKE WITH THE SURGEON BEFORE THE SURGERY TO DISCUSS THE OPERATING PLAN. WHEN THE SURGEON WENT IN TO REMOVE THE GLENOSPHERE, HE CHECKED THE OTHER COMPONENTS AFTER REMOVING THE LINER BY SCREWING IN EXTRACTOR, GIVING 2 OR 3 TAPS AND THE STEM CAME OUT. THE SURGEON THEN DECIDED TO REMOVE ALL ARTHREX HARDWARE. FOLLOW-UP INVESTIGATION: ALL EXPLANTED HARDWARE WAS GIVEN TO THE PATIENT BY THE FACILITY. TO COMPLETE THE PROCEDURE THE SURGEON USED TWO DIFFERENT NON-ARTHREX MANUFACTURER'S PRODUCTS. THE FOLLOWING ARTHREX HARDWARE WAS EXPLANTED DURING THE (B)(6) 2018 REVISION PROCEDURE: AR-9504L UNIVERSAL REVERSE GELNOSPHERE, LOT 160071211. AR-9120-02 UNIVERSAL GLENOID BASEPLATE, LOT 170020915. AR-9501-11CPC UNIVERSAL REVERSE STEM, LOT 2501475610. AR-9502F-42CPC UNIVERSAL REVERSE SUTURE CUP LOT, 160037603. AR-9503L-06 HUMERAL INSERT, LOT 170019310. AR-9145-30 UNIVERSAL GLENOID - PERIPHERAL LOCKING SCREW, LOT 160078810 QTY 2. AR-9165-25 UNIVERSAL GLENOID - CENT
Patient problems: No Code Available
MAUDE report 7283009 ↗
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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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