Arthrex® AR-9564-2839-LATRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867295797), received between Oct 30, 2020 and Oct 17, 2022 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 15615256 ↗
• InjuryJul 11, 2022Use of Device Problem

  ON 6/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9564-2839-LAT GLENOSPHERE WAS IMPLANTED OVER A 24MM TAPER MGS BASE PLATE. THIS WAS DISCOVERED DURING A RTS REVISION PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 6/21/2022. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2022 AND AN AR-9564-2839-LAT GLENOSPHERE WAS IMPLANTED. ON THE SAME DAY, (B)(6) 2022, A REVISION SURGERY TOOK PLACE BECAUSE THE WRONG DEVICE WAS IMPLANTED. DURING REVISION SURGERY, SURGEON EXPLANTED AR-9564-2839-LAT GLENOSPHERE AND REPLACED IT WITH AN AR-9564-2439-LAT GLENOSPHERE. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY WITH THE SAME SURGEON. CASE WAS COMPLETED SUCCESSFULLY AND NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14976199 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem

  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 11730992 ↗
• 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness

  MAUDE report 10763701 ↗