Arthrex® AR-9503-3633-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867296602), received between Mar 22, 2021 and Oct 31, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting 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.

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.

• MalfunctionOct 31, 2023Fitting Problem; Fitting Problem

  ON 10/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9503-3633-6 UNIVERS REVERS MODULAR GLENOID SYSTEM COMBO HUMERAL INSERT AND AN AR-9503-3336-6 COMBINATION HUMERAL INSERT WOULD NOT SIT PROPERLY. THE SURGEON HAD TO USE AN AR-9562-36NL UNIVERS REVERS NON-LOCKING PERIPHERAL SCREW, TO REMOVE THE HUMERAL INSERT. THE CASE WAS DELAYED FOR ABOUT TEN MINUTES, AND IT WAS COMPLETED USING AN AR-9504-06 HUMERAL SPACER AND AN AR-9503-3336-3 COMBINATION HUMERAL INSERT. THIS WAS DISCOVERED DURING AN RTS PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18039120 ↗
• InjuryOct 26, 2021Loosening of Implant Not Related to Bone-Ingrowth

  ON 09/10/2021, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO THE LOOSENING OF THE PROSTHETIC JOINT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 10/5/2021: THE DATE OF PRIMARY PROCEDURE WAS ON (B)(6) 2019 FOR A REVERSE TOTAL SHOULDER REPLACEMENT. THIS PROCEDURE TOOK PLACE AT (B)(6) MEDICAL CENTER, ARTHREX ACCOUNT # (B)(4). THE DATE OF THE REVISION SURGERY WAS ON (B)(6) 2019 FOR A POLY SWAP AND ON ANOTHER ON (B)(6) 2020 FOR A POLY SWAP AND GLENOSPHERE EXCHANGE. THESE REVISION(S) TOOK PLACE AT (B)(6) MEDICAL CENTER, ARTHREX ACCOUNT # (B)(4). THE PART AND LOT NUMBERS OF ALL ARTHREX PARTS THAT WERE EXPLANTED DURING THE REVISION(S) ARE AS FOLLOWED: ON (B)(6) 2019: INSERT (AR-9503-3633-6, LOT 18.02045 (2024-02-29)), PERIPHERAL SCREW (AR-9562-32NL, LOT 2019001013, (2024-03-31)). ON (B)(6) 2020: GLENOSPHERE (AR-9564-2433-LAT, LOT 19.00014 (2024-04-30)), INSERT (AR-9503-3633-3, LOT 19.00010 (2024-04-30)), UNSURE WHICH SPECIFIC SCREW REPLACED. THE PART AND LOT NUMBERS OF ALL ARTHREX PARTS IMPLANTED DURING THE REVISION(S) ARE AS FOLLOWED: ON (B)(6) 2019: UNIVERS REVERS MGS PERIPHERAL SCRE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12696581 ↗
• InjuryMar 22, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A POSSIBLE INFECTION. AR-9503-3633-6 (LOT: 20.00369) WAS EXPLANTED DURING THE REVISION SURGERY. THE PRIMARY AND REVISION SURGERIES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 11547716 ↗