Arthrex® AR-9505-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061422), received between Apr 27, 2021 and May 10, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2021Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method

  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 11801915 ↗
• InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN INFECTION AFTER UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE CAUSING THE NEED FOR IMPLANT REMOVAL. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY AND TOOK PLACE AT THE SAME FACILITY AS THE ORIGINAL SURGERY. THE REVISION TOOK PLACE ON (B)(6) 2021. THE PART AND LOT NUMBERS OF EXPLANTED ARTHREX MATERIAL IS CURRENTLY UNKNOWN. THE PATIENT WAS REVISED WITH HEMI-ARTHROPLASTY, USING ARTHREX APEX. ADDITIONAL INFORMATION RECEIVED ON 4/9/2021: THE REP PROVIDED THE PART/LOT NUMBERS OF EXPLANTED ARTHREX PRODUCT THAT WAS REMOVED DURING THE REVISION SURGERY. SEE EXPLANTED MATERIAL LISTED BELOW; AR-9561-25P / LOT: 8013. AR-9560-28-4 / LOT: 6807. AR-9501-06S / LOT: 19.03511. AR-9502F-39LCPC / LOT: 19.02275. AR-9564-2839-LAT / LOT: 19.01015. AR-9564-2839 / LOT: 19.00603. AR-9562-28NL / LOT: 18.00143. AR-9503M-03 / LOT: 18.01724 AR-9505-06 / LOT: 19.03720.. AR-9563-28 / LOT: 2019003486 (X 2). AR-9562-28NL / LOT: 2019001689.

  Patient problems: Unspecified Infection

  MAUDE report 11730943 ↗