Arthrex® AR-9104-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867057289), received between Nov 13, 2018 and Dec 7, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT TOTAL JOINT REPLACEMENT IN HER SHOULDERS IN 2009 AND 2010. PATIENT IS CURRENTLY UNDER CARE FOR SYSTEMIC SCLEROSIS AND HAS BLOODWORK DONE EVERY 6 MONTHS. THE COBALT/CHROMIUM LEVEL IN HER BLOOD IS INCREASING. AT TIME OF INITIAL REPORT PART NUMBERS WERE NOT PROVIDED BUT HAVE BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED 11/17/20: THE PATIENT UNDERWENT RIGHT SHOULDER SURGERY (B)(6) 2009. PATIENT ALSO HAD LEFT SHOULDER SURGERY (B)(6) 2010 APPROXIMATELY ONE YEAR LATER THE PATIENT HAD A REVISION SURGERY ON THE LEFT SHOULDER BOTH THE (B)(6) 2010 SURGERY AND THE REVISION OF THAT SURGERY WERE DONE BY THE SAME SURGEON/FACILITY AS THE 2009 PROCEDURE. PATIENT IS UNSURE WHAT THE REVISION SURGERY ACTUALLY ENTAILED. PATIENT IS SEEING A RHEUMATOLOGIST FOR HER SYSTEMIC SCLEROSIS AND IT HAS BEEN DISCOVERED THAT SHE HAS COB ALT IN HER BLOOD. PATIENT WAS REFERRED TO HER PRIOR HIP REPLACEMENT SURGEON (DIFFERENT THAN SHOULDER SURGEON).. MRI'S WEE PERFORMED AND SHOWED NO COMPROMISE. PATIENT BELIEVES THIS WAS PERFORMED APPROXIMATELY (B)(6) 2019. AT THIS TIME THEY DO NOT BELIEVE THAT ANY OF HER CURRENT HEALTH ISSUE ARE DUE TO THE COBALT ISSUE. THE CONCERN

  Patient problems: Toxicity

  MAUDE report 10962154 ↗
• InjuryAug 5, 2019Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT RETURNED 3 YEARS AFTER ECLIPSE SURGERY. THE PATIENT HAD RETURNED TO HAVE A REVISION TO A REVERSE PROTHESIS BECAUSE THE PATIENT HAD TORN HER ROTATOR CUFF AND SUBSCAPULARIS MUSCLE. ON XRAY THE KEEL LOOKED TO BE SOLID AND IN PLACE. WHEN THE SURGEON PERFORMED THE SURGERY ON THE SHOULDER HE REALIZED THAT THE KEEL WAS WORN AND HAD FULLY SNAPPED OFF LAYING LOOSE IN THE JOINT. THAT'S WHY THE KEEL WAS REMOVED AND THE SURGEON KEPT GOING WITH THE REVERSE PROTHESIS SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8861285 ↗
• InjuryFeb 19, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SUBJECT UNDERWENT A REVISION RTSA SURGERY ON (B)(6) 2019 WHERE THE FOLLOWING HARDWARE WAS EXPLANTED: AR-9104-01 / LOT: 160055314. IDE-AR-9300-43CPC / LOT: 2501362509. IDE-AR-9343-16 / LOT: 1707001. IDE-AR-9301-02 / LOT: 2501490914. THE REASON FOR THE EXPLANT IS THE SUBJECT HAS A COMPLETE TEAR OF RIGHT ROTATOR CUFF. THIS REVISION IS SECONDARY TO A COMPLETE ROTATOR CUFF TEAR. THE SUBJECT HAS GOOD BONE QUALITY. THERE WAS NO EVIDENCE OF LOOSENING OF THE IMPLANT.

  Patient problems: Injury

  MAUDE report 8349744 ↗
• InjuryNov 13, 2018Break; Component Missing

  IT WAS REPORTED THAT A ECLIPSE WITH METAL BACKED GLENOID WITH POLY WAS IMPLANTED. AFTER 1 YEAR AN X-RAY WAS DONE WERE THE SURGEON SAW THE GLENOID PIECE WAS NOT AS IT SHOULD LIKE. A REVISION TOTAL SHOULDER WAS DONE AND THE SURGEON FOUND THE PE-LINER GLENOID WAS BROKEN. SUPERIOR PARTS WERE ABSENT AND INFERIOR PART WERE STILL IN PLACE. THE BROKEN PART WAS THROWN AWAY AND THE OTHER PIECES OF THE GLENOID WILL BE RETURNED. NO FURTHER INFORMATION AT THE MOMENT. FURTHER QUESTIONS ASKED.

  Patient problems: Failure of Implant

  MAUDE report 8065539 ↗