Arthrex® AR-9503-3639-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867308879), received between May 10, 2021 and Jul 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, 36 (NEUTRAL) AND AN AR-9503-3639-6 36+6 / 39 COMBINATION HUMERAL INSERT FAILED TO LOCK INTO PLACE PROPERLY. THE SURGEON ATTEMPTED TO INSERT THE COMBINATION LINER INTO THE SUTURE CUP, BUT IT WOULD NOT ENGAGE SECURELY. AS NO ADDITIONAL 36+6/39 COMBINATION LINER WAS AVAILABLE IN THE IMPLANT BIN, THE SURGEON HAD TO REMOVE THE ALREADY PLACED IMPLANT, RE-REAM THE GLENOID TO A SIZE 39, AND SWITCH TO ALTERNATIVE IMPLANTS. THIS ISSUE RESULTED IN A 25-MINUTE DELAY TO THE PROCEDURE. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/01/2025: THE ORIGINAL IMPLANT LINER FAILED TO SEAT PROPERLY. ALTHOUGH IT WAS PARTIALLY ENGAGED, IT COULD NOT BE FULLY INSERTED. WHILE ATTEMPTING TO REMOVE THE LINER, THE SURGEON USED AN OSTEOTOME AND INADVERTENTLY BROKE THE LINER INTO TWO PIECES. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. INSTEAD, ALTERNATIVE IMPLANT PART NUMBERS AR-9502F-39CPC AND AR-9503M-06 WERE USED TO COMPLETE THE CASE. THE BONE SOCKET WAS PREPARED USING A SUTURECUP REAMER ON THE HUMERAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518736 ↗
• MalfunctionJan 17, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9503-3639-6 UNIVERS REVERS MODULAR GLENOID SYSTEM, COMBO HUMERAL INSERT, 36 +6 / 39, HAD THE POLLY NOT SEATING CORRECTLY IN A CUP. ANOTHER IMPLANT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/02/2024: THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2024. ANOTHER HUMERAL INSERT WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183073 ↗
• InjuryMay 10, 2021Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INCORRECT SIZED IMPLANTS WERE MISTAKENLY USED DURING A PRIMARY MODULAR GLENOID SYSTEM RTSA SURGERY. THE SIZE OF THE HUMERAL CUP (39) USED WAS MISMATCHED WITH A SIZE 36 GLENOSPHERE. FOLLOWING THE SURGERY, THE MISTAKE WAS NOTICED BY THE AGENCY. THEY PROMPTLY ALERTED THE SURGEON OF THE INCORRECT IMPLANTED PRODUCT. THE SURGEON NOTIFIED THE PATIENT OF THE ERROR, AND THE PATIENT DECIDED TO HAVE THE COMPONENTS CHANGED OUT FOR THE CORRECT SIZES. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO CHANGE OUT THE SIZE OF THE HUMERAL CUP AND GLENOSPHERE. A NEW SPACER AND POLY WERE ALSO ADDED TO MAKE SURE THE COMPONENTS MATCHED. THE PATIENT WAS REVISED WITH THE FOLLOWING MATERIAL; AR-9503M-06 (LOT: 18.00559), AR-9505-06 (LOT: 20.02214), AR-9564-2439-LAT (LOT: 18.00657). THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED DURING THE REVISION SURGERY; AR-9564-2436-LAT (LOT: 20.1788), AR-9505-06 (LOT: 19.04327), AR-9503-3639-6 (LOT: 19.03606).

  Patient problems: Insufficient Information

  MAUDE report 11801797 ↗