Arthrex® AR-9502F-39LCPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867234239), received between Oct 28, 2020 and Oct 17, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2022Break

  ON 9/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN A PATIENT UNDERWENT A REVERSE MODULAR SHOULDER PROCEDURE ON (B)(6) 2020. DURING THIS PROCEDURE AN AR-9501-13S APEX HUMERAL STEM, AN AR-9502F-39LCPC SUTURE CUP, AN AR-9503M-03 HUMERAL INSERT, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AN AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE, WERE SUCCESSFULLY IMPLANTED. TWO YEARS LATER, ON (B)(6) 2022, PATIENT UNDERWENT A REVISION REVERSE TOTAL SHOULDER PROCEDURE BECAUSE THE CENTRAL AND PERIPHERAL SCREWS BROKE OFF THE BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 9/30/2022: DURING REVISION SURGERY ON (B)(6) 2022, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AND AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE WERE REMOVED. PROCEDURE WAS COMPLETED BY IMPLANTING AN AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER FROM LOT NUMBER 18.00756 AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD FROM LOT NUMBER 10248799 WERE IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15615581 ↗
• InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT EXPERIENCED AN INFECTION AFTER UNDERGOING A SHOULDER ARTHROPLASTY PROCEDURE CAUSING THE NEED FOR IMPLANT REMOVAL. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY AND TOOK PLACE AT THE SAME FACILITY AS THE ORIGINAL SURGERY. THE REVISION TOOK PLACE ON (B)(6) 2021. THE PART AND LOT NUMBERS OF EXPLANTED ARTHREX MATERIAL IS CURRENTLY UNKNOWN. THE PATIENT WAS REVISED WITH HEMI-ARTHROPLASTY, USING ARTHREX APEX. ADDITIONAL INFORMATION RECEIVED ON 04/09/2021: THE REP PROVIDED THE PART/LOT NUMBERS OF EXPLANTED ARTHREX PRODUCT THAT WAS REMOVED DURING THE REVISION SURGERY. SEE EXPLANTED MATERIAL LISTED BELOW; AR-9561-25P / LOT: 8013, AR-9560-28-4 / LOT: 6807, AR-9501-06S / LOT: 19.03511, AR-9502F-39LCPC / LOT: 19.02275, AR-9564-2839-LAT / LOT: 19.01015, AR-9564-2839 / LOT: 19.00603, AR-9562-28NL / LOT: 18.00143, AR-9503M-03 / LOT: 18.01724, AR-9505-06 / LOT: 19.03720, AR-9563-28 / LOT: 2019003486 (X 2), AR-9562-28NL / LOT: 2019001689.

  Patient problems: Unspecified Infection

  MAUDE report 11730980 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A ISSUE POSSIBLY RELATED TO AN ARTHREX PRODUCT TOOK PLACE. UPON FURTHER INVESTIGATION THE FOLLOWING WAS DISCOVERED: A PATIENT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY (B)(6) 2019. IT WAS DIAGNOSED VIA X-RAY AND CT SCAN (B)(6) 2020 THAT THE PATIENT WAS EXPERIENCING LOOSENING OF THE IMPLANT GLENOID SIDE. A REVISION OF GLENOID AND HUMERAL COMPONENTS WITH ALLOGRAFT SURGERY WAS PERFORMED (B)(6) 2020 DURING WHICH TIME THE FOLLOWING ORIGINAL ARTHREX IMPLANTS WERE EXPLANTED: ARTHREX UNIVERS REVERS MGS PERIPHERAL SCREW NL 4.5X24 MM; LOT #170182004; CATALOG # AR-9562-24NL. ARTHREX UNIVERS REVERS MGS PERIPHERAL SCREW 4.5X32 MM; LOT #2018001455; CATALOG # AR-9562-32NL; QTY 2. ARTHREX CENTRAL SCREW MODULAR 30 MM; LOT #5652; CATALOG # AR-9561-30S. ARTHREX GLENOSPHERE 39 +4 LAT/24; LOT #18.00656; CATALOG # AR-9564-2439-LAT. ARTHREX CUP UNIVERS REVS SUTURE 39MM NTRL +2 LEFT; LOT #170074105; CATALOG # AR-9502F-39LCPC. ARTHREX BASEPLATE 24 M MODULAR; LOT #5362; CATALOG # AR-9560-24. AFTER REMOVAL OF THE ABOVE DEVICES THE SURGEON PERFORMED A CONVERSION TO HEMIARTHROPLASTY WITH GLENOID BONE GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 10747417 ↗