Arthrex® AR-9347-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867060043), received between Aug 20, 2020 and Jun 16, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED FROM AN ECLIPSE + UNIVERSAL GLENOID TO UNIVERS LAPEL WITH UNIVERSAL GLENOID GLENOSPHERE. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY WAS REQUIRED DUE TO HUMERAL LOOSENING OF THE ECLIPSE PROSTHESIS. ACCORDING TO THE SURGEONS STATEMENT THE IMPLANT WAS ORIGINALLY POORLY INSERTED. DURING THE REVISION, HOWEVER, IT WAS NOTED THAT THE GLENOID PE INSERT OF THE UNIVERSAL GLENOID LOOKED UNUSUAL. THE GLENOID INSERT WAS PROBABLY SUBJECTED TO DECENTRALIZED LOADING DUE TO THE POOR POSITIONING OF THE HUMERAL COMPONENT AND THEREFORE SHOWED UNUSUAL WEAR PATTERNS. HOWEVER, IT WAS ALSO NOTICEABLE THAT A KIND OF LAYER HAD COME LOOSE ON THE GLENOID INSERT ("DELAMINATION"). THE AFFECTED DEVICES AR-9121-02, AR-9347-18, AR-9300-47 AND AR-9301-01 WERE REMOVED AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 22211916 ↗
• InjuryMay 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/15/2025, A CLINDEX NOTIFICATION WAS RECEIVED VIA EMAIL INDICATING THAT A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED A SUBSCAPULARIS FAILURE. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE, CONVERTING TO A DIFFERENT TYPE OF ARTHROPLASTY. THE INITIAL ECLIPSE PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2024. THE EVENT WAS DETERMINED TO BE UNRELATED TO THE ORIGINAL SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 21995257 ↗
• MalfunctionJun 7, 2024Degraded; Degraded

  IT WAS REPORTED THAT AFTER AN INITIAL SHOULDER PROSTHESIS SURGERY ON (B)(6) 2020 THE PATIENT REALIZED, IN SUMMER 2021, SLIGHT CRACKING NOISES IN THE LEFT SHOULDER. DURING AN EXAMINATION IN (B)(6) 2021 THE ORTHOPAEDIST OF THE PATIENT IDENTIFIED CHANGES ON THE X-RAYS. IT WAS REPORTED THAT A CHANGE OF THE PLASTIC PAN WAS IDENTIFIED. AFTER TWO ADDITIONAL EXAMINATIONS BY THE ORTHOPAEDIST IT APPEARS THAT THE WEAR OF THE PLASTIC PAN ALS LEADS TO A LOOSENING OF THE PAN. NO FURTHER INFORMATION WERE PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19484797 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED WITH AN ARTHREX PRODUCT INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 14-MAY-2020, ASA: CONFIRMATION RECEIVED THAT PERFORMED SURGERY WAS A REVISION OF AN ECLIPSE WITH AN PEG-GLENOIDE FIVE YEARS AFTER INITIAL SURGERY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15137842 ↗
• 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 14337532 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ECLIPSE TOTAL SHOULDER CASE NEEDED A REVISION DUE TO A FAILED RCR. THERE WAS NO REPORT OF AN EVENT THAT CAUSED THE FAILURE. THE CALLER DID NOT KNOW THE ORIGINAL DATE OF SURGERY (STATED ONLY THAT IT WAS 'YEARS AGO'). THE PATIENT IS MALE, 64 YEARS OLD. THE DEVICES FROM THE ORIGINAL CASE WERE REMOVED; THESE WERE REPLACED WITH AR-9502F-39CPC, AR-9501-10P, AR-9503M-03.

  Patient problems: Failure of Implant

  MAUDE report 11799903 ↗
• InjuryAug 20, 2020Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2020. THE GLENOID GOT LOOSE POST OP. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER. THE DEVICE WILL NOT RETURN FOR INVESTIGATION. UPDATE 05-MAR-2020: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2014. UPDATE 06-AUG-2020: FURTHER INFORMATION WERE PROVIDED THAT THE FOLLOWING DEVICES WERE ALSO EXPLANTED DURING THE INITIAL REVISION SURGERY. AR-9347-18 BATCH 1295131706. AR-9300-47CPC BATCH12.744. AR-9301-02 BATCH 13.389.

  Patient problems: Failure of Implant

  MAUDE report 10431422 ↗