Arthrex® AR-9104-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867057302), received between May 24, 2018 and Aug 13, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• InjuryAug 13, 2019Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2019 WHERE THE GLENOID POLY W/ KEEL, AR-9104-03, WAS EXPLANTED. THE PATIENT SUFFERED A ROTATOR CUFF TEAR HOWEVER, THE FAILURE IS NOT RELATED TO THE IMPLANT. THE FOLLOWING WAS ALSO IMPLANTED: IDE-AR-9300-49CPC / LOT: 150070712; IDE-AR-9301-03 / LOT: 160109817; IDE-AR-9349-20 / LOT: 1706002. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: AFTER THE ORIGINAL PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND LIMITED RANGE OF MOTION. AN MRI WAS ORDERED AND UNCOVERED A ROTATOR CUFF TEAR. THE REVISION WAS PERFORMED AT THE SAME FACILITY WITH THE SAME SURGEON AS THE FIRST SURGERY. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE REVISION: AR-9560-28-4 / LOT: 5662; AR-9561-35S / LOT: 5690; AR-9564-2842-LAT / LOT: 18.01739; AR-9563-28 / LOT: 2019000055 X3; AR-9563-28 / LOT: 2018035253; AR-9501-13S / LOT: 18.00400; AR-9502F-42CPC / LOT: 18.01658; AR-9503L-06 / LOT: 19.00081. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE DATE OF THE FIRST SURGERY WAS (B)(6) 2018.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 8887273 ↗
• InjuryJan 30, 2019Migration

  IT WAS REPORTED THAT IN AN (B)(6) STUDY, THE LARGE GLENOID POLY WITH KEEL, AR-9104-03, WAS EXPLANTED DUE TO ROTATOR CUFF DYSFUNCTION WITH PROXIMAL HUMERAL MIGRATION IN THE LEFT SHOULDER. THE SUBJECT ((B)(6)) RECEIVED A REVERS TOTAL SHOULDER AFTER THE EXPLANT. THE EXPLANTED HARDWARE IS AS FOLLOWS: DEVICE PART NUMBERS AND LOTS: UNIVERS GLENOID: REF AR-9104-03, LOT 160055515. ARTHREX ECLIPSE HUMERAL HEAD: REF IDE-AR-9349-18, LOT 1419036. ARTHREX ECLIPSE HOLLOW SCREW, MEDIUM, UNCEMENTED: REF IDE-AR-9301-02, LOT 2501490914. ARTHREX ECLIPSE TRUNION, TPS CAP COATED 49MM: REF IDE-AR-9300-49CPC, LOT 150070712.

  Patient problems: Foreign Body In Patient

  MAUDE report 8289613 ↗
• InjuryMay 24, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS ORIGINALLY REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE IN 2010. THE PATIENT'S X-RAYS SHOWED A LOOSE GLENOID AND POTENTIAL LOOSE COMPONENTS OF THE USP II HUMERAL HEAD. THE SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2018 AND REMOVED THE HUMERAL HEAD (AR-9152-20P, LOT: 08006502, LINE: 233554) AND THE TRUNION, AS WELL AS THE GLENOID (PART NUMBER UNKNOWN). THE SURGEON USED ALLOGRAFT BONE CHIPS DUE TO LACK OF BONE ON THE GLENOID. NO GLENOID WAS ABLE TO BE IMPLANTED. THE SURGEON REPLACED THE HUMERAL HEAD AND PUT IN A NEW TRUNION. NO KNOWN INFECTIONS HAVE BEEN REPORTED. NO FURTHER DETAILS, ADDITIONAL INFORMATION HAS BEEN REQUESTED. FOLLOW-UP INVESTIGATION: THE PATIENT WAS EXPERIENCING DISCOMFORT THAT BEGAN A YEAR PRIOR TO THE REVISION SURGERY. THE SAME SURGEON PERFORMED BOTH SURGERIES AT THE SAME FACILITY. THE SURGEON REPLACED THE HUMERAL HEAD WITH AN AR-9152-20P, LOT: 101249339 AND PUT IN A NEW TRUNION, AR-9100TK, LOT: 150038811. THE PART NUMBER OF THE GLENOID HAS BEEN CONFIRMED TO BE AR-9104-03 (LOT: UNKNOWN, LINE 234164).

  Patient problems: Discomfort

  MAUDE report 7540117 ↗