Arthrex® AR-9504L-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867061347), received between Nov 1, 2016 and Nov 23, 2020 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE, THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #(B)(4)) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT, WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #((B)(4)) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER IM

  Patient problems: Foreign Body In Patient

  MAUDE report 10884404 ↗
• InjuryOct 30, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT HAD A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. THE PATIENT RETURNED TO THE OR FOR A REVISION PROCEDURE ON (B)(6) 2019 DUE TO THE IMPLANTED GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE. DURING THE ORIGINAL PROCEDURE, THE CENTRAL SCREW DEPTH GAUGE WAS USED TO ENSURE THAT THE CENTRAL SCREW WAS FULLY SEATED. AFTER GLENOSPHERE IMPACTION, THE GLENOSPHERE FORCEPS WERE USED IN MULTIPLE PLANES TO ENSURE ENGAGEMENT OF THE MORSE TAPER. DURING THE REVISION PROCEDURE THE ORIGINAL GLENOSPHERE (AR-9120-02 / LOT: 18.01057) AND BASEPLATE (AR-9504L-04 / LOT: 18.00719) WERE EXPLANTED, AND THE SURGEON IMPLANTED A MGS BASEPLATE (AR-9560-28-2 / LOT: 5642) AND GLENOSPHERE (AR-9564-2842-LAT / LOT: 18.00802) IN ITS PLACE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON, AND TOOK PLACE AT THE SAME FACILITY. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE: AR-9120-02 // LOT: 18.01057 // QTY.: 1. AR-9145-24 // LOT: 18.00674 // QTY.: 1. AR-9145-30 // LOT: 18.01275 // QTY.: 1. AR-9165-20NL // LOT: 10247862 // QTY.: 1. AR-9501-12P // LOT: 18.00906 // QTY/: 1. AR-9502F-42CPC // LOT: 160037703 // QTY.: 1. AR-9503L-03C // LOT

  Patient problems: No Information

  MAUDE report 9254829 ↗
• InjuryAug 5, 2019Detachment of Device or Device Component

  IT WAS REPORTED APPROXIMATELY ONE AND A HALF WEEKS AFTER HAVING A PRIMARY REVERSE SHOULDER ARTHROPLASTY PROCEDURE, THE PATIENT'S GLENOSPHERE DISASSOCIATED POST-OP. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE THAT TOOK PLACE ON (B)(6) 2018: AR-9507S // LOT: 10232680, AR-9165-25NL // LOT: 10221985, AR-9120-03 // LOT: 18.00430, AR-9145-30 // LOT: 18.00677, AR-9145-24 // LOT: 18.00574, AR-9504L-04 // LOT: 18.00719, AR-9501-06P // LOT: 170151305, AR-9502F-42CPC // LOT: 170161207, AR-9550-06 // LOT: 18.00355, AR-9503L-03C // LOT: 18.00110. IT IS UNKNOWN IF THE PATIENT WAS EXPERIENCING ANY PAIN OR DISCOMFORT. THE DISASSOCIATION WAS DISCOVERED APPROXIMATELY ONE AND A HALF WEEKS POST-OP DURING PHYSICAL THERAPY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018. THE REP STATED COPIES OF X-RAY'S ARE NOT AVAILABLE, NOR WERE ANY PICTURES TAKEN. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 // LOT: 18.00719, AR-9550-06 // LOT: 18.00355, AR-9503L-03C // LOT: 18.00110. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE REV

  Patient problems: Failure of Implant

  MAUDE report 8861324 ↗
• InjuryApr 5, 2018Disassembly

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNIVERS REVERSE TSA ON (B)(6) 2018. THE SAME SURGEON PERFORMED A REVISION UNIVERS REVERSE TSA PROCEDURE ON (B)(6) 2018 DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE AT THE MORSE TAPER. FOLLOW-UP INVESTIGATION: AN L/42 HUMERAL INSERT (AR-9503L-03 / LOT: 170016710, LINE 226431) AND AN 42+4 UNIVERS REVERS GLENOSPHERE (AR-9504L-04 / LOT: 17009813, LINE 226918) WERE IMPLANTED DURING THE ORIGINAL PROCEDURE ON (B)(6) 2018 AND EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2018. X-RAYS WERE TAKEN HOWEVER, NOT YET PROVIDED. THE EXPLANTED HARDWARE WAS REPLACED WITH THE FOLLOWING: AR-9404L-04, LOT: 170009813. AR-9503L-06, LOT: 170005010.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7398758 ↗
• InjuryNov 1, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A MALE PATIENT HAD UNDERGONE A RIGHT REVERSE TOTAL SHOULDER PROCEDURE APPROXIMATELY TWO YEARS PRIOR IN ANOTHER STATE. ON (B)(6) 2016 PATIENT WAS UNDERGOING A PROCEDURE TO REMOVE THE PRIOR IMPLANTS DUE TO INFECTION. DURING THE PROCEDURE SURGEON WAS USING THE AR-8943-10, T15 HEXALOBE SCREWDRIVER ((B)(4)) AND THE THREADS TWISTED MAKING IT NO LONGER USABLE. THEN THE SURGEON USED THE AR-9202-T15H, UNIVERSAL GLENOID T15 LONG DRIVER ((B)(4)) AND FOUND THE THREADS TWISTED RENDERING IT UNUSABLE. THESE DEVICES ARE FROM LOANER SET RAR-9501GS #14. NO PATIENT INJURY REPORTED. THE CASE WAS COMPLETED USING HOSPITAL OWNED SPARE SCREWDRIVERS WHICH WERE ALSO IN BAD CONDITION. INFORMATION OBTAINED 10/13/16: PRIOR TO THE REVISION PROCEDURE PATIENT HAD A NORMAL BLOODWORK IN 2014, ASPIRATION OF 45CC IN (B)(6) 2016 AND POSITIVE TEST FOR PROPIONIBACTERIUM ACNES. AT THE TIME OF THE REVISION AN EXTENDED HOLD CULTURE WAS DONE AND READ ON (B)(6) 2016 AS WELL AS (B)(6) 2016 AND IS CURRENTLY ONGOING. NO AEROBES ISOLATED OR ANEROBIC GROWTH OF BACTERIA FOUND. NO EVIDENCE OF MALIGNANCY. THE FOLLOWING PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE: AR-9504L-04 ((B)(4)), AR-9502-42RCPC ((B)(

  Patient problems: Bacterial Infection

  MAUDE report 6068914 ↗