Arthrex® AR-9121-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867057463), received between Aug 10, 2021 and Jun 20, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Erosion” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION RECEIVED ON 7/23/2024: THE INTENDED PROCEDURE WAS AN ANATOMIC SHOULDER WITH A UNIVERSAL CONVERTIBLE BASEPLATE BUT SINCE THE ARTHREX UNIVERSAL GLENOID WOULD NOT PRESS ONTO THE BASEPLATE, THE SURGEON COMPLETED THE CASE AS A REVERSE PROCEDURE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579466 ↗
• MalfunctionAug 25, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER PROCEDURE ON (B)(6) 2021 WHERE AN ARTHREX IMPLANT WAS REMOVED. NO FURTHER DETAILS, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 08/19/2021: THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 FOR A LEFT TOTAL SHOULDER ARTHROPLASTY. THIS PROCEDURE TOOK PLACE AT (B)(6) SURGERY CENTER, ARTHREX ACCOUNT # (B)(4). REVISION FOR A LEFT ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY TOOK PLACE AT ARTHREX ACCOUNT # (B)(4) ON (B)(6) 2021 WHERE THE FOLLOWING DEVICES WERE EXPLANTED: AR-9301-02 (20.00960); AR-9301-47CPC (19.04096); AR-9347-20 (2797, 47/20); AR-9121-06 (17.01402).

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

  MAUDE report 12364477 ↗
• InjuryAug 10, 2021Material Erosion

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY AS THE GLENOID COMPONENT ABRADED. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

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

  MAUDE report 12300879 ↗