Arthrex® AR-9563-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867296923), received between Sep 16, 2020 and Apr 16, 2026 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 24895166 ↗
• MalfunctionOct 17, 2022Break

  ON (B)(6) 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 (B)(6) 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 15615341 ↗
• InjurySep 16, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT (B)(6) 2019 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD AN AUTOGRAFT TO THE GLENOID ON HER INITIAL SURGEY AND IT DID NOT APPEAR TO HAVE HEALED. THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE REVISION REPORTS THAT THE SURGEON HAD MENTIONED IN SURGERY THAT HE BELIEVED THAT THE LOCKING MECHANISM ON THE BASEPLATE MAY NOT HAVE BEEN FUNCTIONING APPROPRIATELY (THE SCREW WAS NOT LOCKED IN). DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX DEVICES HAD BEEN IMPLANTED: AR-9564-2436-LAT, GLENOSPHERE, LOT 18.00689 . AR-9503S-03, HUMERAL INSERT, LOT 18.00870 . AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 170141708. AR-9561-25P, MODULAR CENTRAL POST, LOT 5368 . AR-9560-24-2, MODULAR BASEPLATE, LOT 5408. AR-9562-36NL, PERIPHERAL SCREW NON-LOCKING, LOT 2018001207. AR-9563-36, PERIPHERAL SCREW LOCKING, LOT 2018001490. AR-9563-40, PERIPHERAL SCREW LOCKING, LOT 2018001491. AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, LOT 170125705. DURING THE REVISION SURGERY ALL OFF THE ABOVE LISTED ORIGINAL IMPLANTS WERE EXPLANTED, EXCEPT FOR THE AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, WHICH WAS LEF

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 10540449 ↗