Arthrex® AR-9564-2839Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295773), received between Apr 27, 2021 and Feb 1, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjuryFeb 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/9/2024, IT WAS REPORTED ON CASE NUMBER (B)(4) BY A SALES REPRESENTATIVE VIA (B)(4) THAT A REVISION REVERSE TSA PROCEDURE OCCURRED ON (B)(6) 2024 FOR UNKNOWN REASONS. DURING THE PROCEDURE, IT WAS REPORTED THAT AN AR-9545-T15-01 DRIVER SHAFT WAS STRIPPED WHEN TRYING TO REMOVE SCREWS FROM THE MGS BASEPLATE. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED PATIENT HARM AND NO FURTHER INFORMATION PROVIDED. NO PIECES BROKE INSIDE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON WHAT CAUSED THE NECESSARY REVISION SURGERY ON (B)(6) 2024 ON (B)(4) FOR CASE NUMBER (B)(4) . ADDITIONAL INFORMATION WAS RECEIVED ON 1/31/2024: ON 1/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A PATIENT HAD UNDERGONE A REVISION REVERSE TSA PROCEDURE ON (B)(6) 2024 DUE TO AN INFECTION. ALL COMPONENTS HAD TO BE REMOVED, AND THE SUTURE CUP HAD TO BE SEPARATED FROM THE STEM FOR EXPLANTATION. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2023 AT THE SAME FACILITY. NO NEW PRODUCTS WERE IMPLANTED AFTER EXPLANTATION. THE CASE WAS COMPLETED USING ANOTHER AR-9545-T15-01 DRIVER SHAFT TO REMOVE THE SUTURE CUP. THE SURGEON STATED THE PATIENT'S CURRENT HEALTH STATUS HAD BEEN REPORTED AS

  Patient problems: Unspecified Infection

  MAUDE report 18623895 ↗
• MalfunctionJun 28, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RTSA PROCEDURE ON (B)(6) 2020. A REVISION WAS THEN PERFORMED DUE TO A LOOSENED GLENOSPHERE ON (B)(6) 2021 WHERE THE FOLLOWING DEVICES WERE EXPLANTED: AR-9564-2839 LOT: 19.00602 AR-9503M-06 LOT: 19.04678.

  Patient problems: Failure of Implant

  MAUDE report 12075671 ↗
• 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 4/9/2021: 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 11730994 ↗