Arthrex® AR-9503L-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867061217), received between Nov 1, 2016 and Sep 14, 2026 — classified as 3 injuries, 2 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Incomplete or Inadequate Connection

  On 31-Aug-2026, a sales representative reported via email that an AR-9503L-03 Arthrex UNIVERS REVERS Humeral Insert LARGE / 42 / +3 would not connect with the suture cup during a reverse shoulder procedure performed on (b)(6) 2026. The surgeon opened another humeral liner, which successfully mated with the suture cup. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758592 ↗
• MalfunctionMar 12, 2025Positioning Failure; Positioning Failure

  ON 2/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9503L-03 ARTHREX UNIVERS REVERS HUMERAL INSERT WAS NOT SEATING PROPERLY IN THE SUTURECUP. THE SURGEON WAS CONCERNED THAT THE TAPER WAS NOT ENGAGING WITH THE CUP PROPERLY. THE SURGEON CONFIRMED THERE WAS NO DEBRIS IN THE CUP AND CLEANED OFF THE HUMERAL INSERT BUT IT STILL COULD NOT ENGAGE. THIS WAS DISCOVERED DURING A REVERS TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 3/3/2025.

  Patient problems: Insufficient Information

  MAUDE report 21582361 ↗
• 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 17959204 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 3/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A SHOULDER ARTHROPLASTY REVISION SURGERY TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9560-28 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAR BASEPLATE, AN AR-9502F-42LCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9564-2842 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503L-03 ARTHREX UNIVERS REVERS HUMERAL INSERT, (2) AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9562-28NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9562-40NL UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL NON-LOCKING SCREW, AN AR-9561-25P UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL POST MODULA, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16582097 ↗
• 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)(4)) AND THE THREADS TWISTED MAKING IT NO LONGER USABLE. THEN THE SURGEON USED THE AR-9202-T15H, UNIVERSAL GLENOID T15 LONG DRIVER ((B)(4)) 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 PROPIONIBACTERIUM 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)(4)), AR-9502-42RCPC ((B

  Patient problems: Unspecified Infection

  MAUDE report 6068922 ↗