Arthrex® AR-9121-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867057432), received between Apr 30, 2019 and Jul 26, 2024 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A METALLOSIS. THE IMPLANT WAS IMPLANTED FOUR YEARS AGO WITH BONE GRAFT AUGMENTATION. NO FURTHER INFORMATION WAS PROVIDED. UPDATE DW 12-JUL-2024: FURTHER INFORMATION WERE PROVIDED THAT DURING AN INITIAL SURGERY ON (B)(6) 2020 THE FOLLOWING DEVICES WERE IMPLANTED DUE TO AN OMARTHROSIS WITH B2 GLENOID SITUATION WITH A RETRO OF JUST UNDER 30 DEGREES. AR-9120-03, AR-9165-25NL, AR-9145-36, AR-9121-03, AR-9300-45CPC, AR-9301-04. ON (B)(6) 2024 THE REVISION SURGERY WAS PERFORMED. AS PART OF THE REVISION THE ECLIPSE AND UNIVERSAL GLENOID WERE ALL REMOVED DUE TO A SEVERE METALLOSIS. THE SURGEON DECIDED TO FIRST BUILD UP THE GLENOID WITH ALLOGRAFT IN A TWO-SIDED PROCEDURE AND TO INSERT A CEMENT SPACER ON THE HUMERUS SIDE. IN THE SECOND STEP - A UNIVERS REVERSE WILL BE INSERTED IN AUTUMN WITH PLANNING.

  Patient problems: Metal Related Pathology

  MAUDE report 19837473 ↗
• MalfunctionJun 21, 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 19579895 ↗
• MalfunctionJun 20, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576766 ↗
• InjuryJun 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/2/2023, IT WAS REPORTED BY A PATIENT THAT AN ARTHREX ECLIPSE STEMLESS HUMERAL IMPLANT AND CONVERTIBLE UNIVERSAL GLENOID PRODUCTS WERE IMPLANTED DURING A SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2023. THE PATIENT IS EXPERIENCING A POSSIBLE UNSPECIFIED REACTION. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17199320 ↗
• InjuryApr 28, 2023Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY AS THE INLAY WAS DISLOCATED. THE INLAY AND THE HUMERAL HEAD WERE REPLACED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16838478 ↗
• InjuryMay 9, 2022Degraded

  IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.

  Patient problems: Failure of Implant

  MAUDE report 14336843 ↗
• MalfunctionDec 28, 2020Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE A REVISION ON HIS SHOULDER. ORIGINAL DOS (B)(6) 2019 FOR A TOTAL SHOULDER. PER THE PATIENT, HE WAS SWATTING A FLY AND THE PLASTIC PIECE OF THE GLENOID DETACHED IN HIS SHOULDER. THE REVISION CASE WAS (B)(6) 2020. AN AR-9121-03 AND THE STEM (UNKNOWN PART #) WERE REMOVED. THE CASE WAS CONVERTED TO A REVERSE SHOULDER, A 42 GLENOPSHERE AND CUP WERE IMPLANTED. PATIENT IS MALE, (B)(6) YEARS.

  Patient problems: Insufficient Information

  MAUDE report 11075959 ↗
• InjuryApr 30, 2019Break

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A SHOULDER SURGERY ON (B)(6) 2014. HE EXPERIENCED A TRAUMA ON (B)(6) 2018. HE FELL ON AN ICE PLATE IN WINTER. ON (B)(6) 2018 IT WAS NOTICED THAT THE PE-INLAY IMPLANT BROKE. THE IMPLANT WAS REMOVED ON (B)(6) 2018. A NEW IMPLANT WAS IMPLANTED ON (B)(6) 2018. NO FURTHER INFORMATION HAD BEEN MADE AVAILABLE. WE DO NOT HAVE ANY INFORMATION ON PART NUMBER / IF IT IS AN ARTHREX DEVICE / WHICH CUSTOMER WAS THE OPERATING HOSPITAL ETC. ARTHREX IS STILL WORKING ON RECEIVING FURTHER INFORMATION SO THIS INCIDENT CAN BE EVALUATED. UPDATE 08-APR-19: FOLLOWING DEVICES WERE IMPLANTED ON INITIAL SURGERY: AR-9349-20 (LOT.: 1295124702), AR-9301-02 (LOT.: 2501338911), AR-9121-03 (LOT.: 1031003), AR-9300-49CPC (2501321807). ONLY AR-9121-03 BROKE. UPDATE 09-APR-19: IT WAS ALSO MENTIONED THAT DUE TO PAIN IN THE LEFT SHOULDER AN ARTHROSCOPY IN THE LEFT SHOULDER TOOK PLACE FOR CONTROL. IT WAS NOT POSSIBLE FOR THE CUSTOMER TO TELL US IF THOSE IMPLANTS WERE ARTHREX DEVICES. NO PART NUMBERS OR LOT NUMBERS AVAILABLE. BUT THE SURGEON CONFIRMED THAT THERE WAS NOTHING WRONG WITH THE IMPLANT IN THE LEFT SHOULDER. HE CANT PROVIDE US THE INFORMATION WHERE THE PAIN IN THE PATI

  Patient problems: Fall; Pain

  MAUDE report 8566432 ↗