Arthrex® AR-9560-28-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867296480), received between Oct 30, 2020 and Feb 1, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 5 most recent of 5 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 203166 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)(6). 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 G

  Patient problems: Unspecified Infection

  MAUDE report 18622869 ↗
• MalfunctionOct 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 15615422 ↗
• MalfunctionMay 16, 2022Break

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO A PROSTHETIC JOINT IMPLANT FAILURE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A SUPSCAP REPAIR SHOULDER ARTHROPLASTY. UPDATE 27-APR-2022: THE CENTRAL SCREW AND ONE PERIPHERAL SCREW HAD BROKEN AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO THE LOOSENING OF THE BASEPLATE. THE PROBLEM WAS IDENTIFIED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 14407328 ↗
• 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 11730969 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT MAY HAVE HAD AN ISSUE AS A RESULT OF SURGERY INVOLVING ARTHREX IMPLANTS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD A (B)(6) 2019 REVERSE SHOULDER REPLACEMENT PROCEDURE. AFTER THE NERVE BLOCK HAD WORN OFF, APPROXIMATELY 24 HOURS POST SURGERY THE PATIENT WAS EXPERIENCING NUMBNESS IN THE SURGICAL ARM'S PALM, HALF OF RING FINGER AND THE PINKIE FINGER. THE PATIENT WAS DIAGNOSED WITH ULNAR NERVE PALSY AND TOLD IT MAY TAKE A YEAR TO RESOLVE. PATIENT CONSULTED WITH A NEUROLOGIST, WHO SAID NOTHING COULD BE DONE. THE ULNAR NERVE WAS DAMAGED. NO SECOND SURGERY HAS BEEN PERFORMED. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED (B)(6) 2019: AR-9560 28-4 / LOT: 6094. AR-9561-25P / LOT: 5685. AR-9502F-39RCPC / LOT: 19.00275. AR-9501-105 / LOT: 18.0037. AR-9564-2839-LAT / LOT: 18.02027. AR-9562-28NL / LOT: 2018005880. AR-9503M-06 / 19.00667. AR-9563-28 / LOT: 2019001687. AR-9563-24 / LOT: 19.02242. AR-9562-28NL / LOT: 2018005880.

  Patient problems: Nerve Damage; Numbness

  MAUDE report 10763570 ↗