Arthrex® AR-9121-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867057418), received between Apr 9, 2019 and Feb 26, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A REVISION OF AN ECLIPSE WITH UNIVERSAL GLENOID WAS NECESSARY DUE TO WEAR OF THE POLYETHYLENE GLENOID OF THE UNIVERSAL GLENOID BASE PLATE. IT WAS FURTHER REPORTED THAT THE ISSUE CAUSE A STRONG METALLOSIS DUE TO THE METAL TO METAL FRICTION. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: CD-9341-16 ECLIPSE HEAD, SIZE 41/16 TINBN COATED AR-9300-41CPC ECLIPSE TRUNION,41 MM TPS CTD AR-9301-02 ECLIPSE CAGE SCREW M, 35MM AR-9120-01 UNIVERSAL GLENOID - BASEPLATE SMALL AR-9165-20 UNIVERSAL GLENOID - CENTRAL SCREW 20MM 2X UNKNOWN PERIPHERAL SCREWS

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18779571 ↗
• InjuryOct 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A LOOSENING OF THE ECLIPSE PROSTHESIS LED TO REVISION TO UNIVERS REVERS. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED: ECLIPSE HEAD, ECLIPSE TRUNION, ECLIPSE CAGE SCREW AND UNIVERSAL GLENOID INLAY. THE UNIVERSAL GLENOID HAD A GOOD ANCHORAGE, SO THE PE WAS REMOVED AND A GLENOSPHERE WAS INSTALLED. ON THE HUMERAL SIDE AN ECLIPSE REMOVED AND UNIVERS REVERS INSTALLED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 03-OCT-2023; FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON THE (B)(6) 2017 AND THE FOLLOWING DEVICES WERE IMPLANTED: AR-9145-30, LOT: 160058310. AR-9165-15, LOT: 160064010. AR-9120-01, LOT: 160061912. AR-9145-36, LOT: 160058410. AR-9121-01, LOT: 160101410. AR-9300-41CPC, LOT: UNK.

  Patient problems: Failure of Implant

  MAUDE report 17994904 ↗
• InjuryApr 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A SUBLUXATION. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE PROSTHESIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Subluxation

  MAUDE report 16838379 ↗
• InjuryNov 16, 2022Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING, INLAY IS ABRADED AND A RECONSTRUCTION WITH PELVOPLASTY. AN INVERSE PROSTHESIS IS ALSO PLANNED. THE EVENT REQUIRED A STATIONARY TREATMENT AND RESULTS IN ANOTHER.

  Patient problems: Failure of Implant

  MAUDE report 15806967 ↗
• InjuryJan 31, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY OF A ECLIPSE WITH UNIVERSAL GLENOID WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 19-JAN-2022: FURTHER INFORMATION WERE PROVIDED THAT THE REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING. IT WAS FURTHER REPORTED THAT A PROGRESSIVE POLYETHYLENE ABRASION WITH PRONOUNCED METALLOSIS WAS IDENTIFIED AS WELL. THEREFORE THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS.

  Patient problems: Metal Related Pathology

  MAUDE report 13397023 ↗
• InjuryApr 9, 2019Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN INSERTION OF AN ECLIPSE PROSTHESIS WITH UNIVERSAL GLENOID ON (B)(6) 2016. AFTER TWO YEARS THE AR-9121-01 GLENOID INLAY IS PARTLY RUBBED AND DAMAGED. THE PATIENT WAS REPORTED TO HAVE BEEN DOING WELL AFTER SURGERY WITH A NORMAL HEALING PROCESS. THE PATIENT BEGAN COMPLAINING ABOUT PAIN SPREADING TO THE VENTRAL UPPER ARM. HE HAD THIS PAIN FOR ABOUT 4 WEEKS PRIOR TO (B)(6) 2019. THE PATIENT EXPERIENCED NO TRAUMA. THE PATIENT UNDERWENT PAIN MEDICATION BUT THERE WAS NO IMPROVEMENT. IT WAS REPORTED THAT THE PATIENT HAD NO FEVER WITH RELATION TO THIS INCIDENT. ON (B)(6) 2019 THERE WAS A REVISION SURGERY WHERE THE PE INLAY WAS EXCHANGED AND IN ADDITION AR-9343-18 HUMERAL HEAD WAS EXCHANGED ALSO. UPDATE (B)(6) 2019: AR-9343-18 WAS EXCHANGED BECAUSE THIS NEEDED TO BE REMOVED FOR THE EXCHANGE OF THE INLAY. REVISION SURGERY WAS FINISHED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8495649 ↗