Arthrex® AR-9564-2433Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867295643), received between Aug 5, 2020 and Jul 21, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 8/8/2025: THE FACILITY REPRESENTATIVE INDICATED THAT THE DISLOCATION WAS INITIALLY NOTED TO BE "PROBABLY RELATED" TO ARTHREX PRODUCTS IN ERROR. IT SHOULD HAVE BEEN NOTED AS "NOT RELATED."

  Patient problems: Joint Dislocation

  MAUDE report 22554663 ↗
• InjuryJul 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 7/9/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS. IMAGES WERE TAKEN ON 6/19/2024, SHOWING THE PATIENT NO LONGER HAD THE ORIGINAL ARTHREX IMPLANTS FROM THE ORIGINAL SURGERY ON (B)(6) 2022. UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED ON (B)(6) 2022 AT AN OUTSIDE FACILITY. AN AR-9501-09S UNIVERS REVERS APEX HUMERAL STEM SIZE 9, AN AR-9502F-36RCPC ARTHREX UNIVERS REVERS SUTURE CUP 36 MM, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE 20 MM, AN AR-9580-2420-2 UNIVERS REVERS MODULAR GLENOID SYSTEM, AUGMENTED BASEPLATE 24 MM +2, 20 DEGREE FULL, TWO AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9503-3633-3C UNIVERS REVERS MODULAR GLENOID SYSTEM CONSTRAINED COMBO HUMERAL INSERT 36 +3C / 33, AN AR-9564-2433 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE 33/24, AND TWO AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 24 MM, WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION OTHER THAN THE DATE OF SURGERY WAS AVAILABLE F

  Patient problems: Insufficient Information

  MAUDE report 19829643 ↗
• InjuryJun 2, 2022Unstable; Naturally Worn

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A RIGHT SHOULDER RTSA ON (B)(6) 2019. PATIENT UNDERWENT A REVISION SURGERY DUE TO CHRONIC INSTABILITY OF THE GLENOID, WHICH APPEARED TO BE WORN OUT. HOWEVER, SALES REPRESENTATIVE COULD NOT CONFIRM IF ANY OF THE ARTHREX IMPLANTED DEVICES HAD BROKEN.ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022:THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2019 AND PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ON (B)(6) 2019, AN AR-9501-05P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503-3633-3 HUMERAL INSERTER, (2) AR-9560-24 BASEPLATE, FROM DIFFERENT LOT NUMBERS, AN AR-9561-20S CENTRAL SCREW, AN AR-9561-25S CENTRAL SCREW, (3) AR-9563-16 PERIPHERAL LOCKING SCREWS, ONE BEING FROM A DIFFERENT LOT NUMBER, AND AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2020. HOWEVER, DURING REVISION SURGERY ON (B)(6) 2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCRE

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

  MAUDE report 14573587 ↗
• MalfunctionAug 5, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT HAS BEEN REPORTED THAT A PATIENT WAS UNDERGOING A REVISION SURGERY. SALES REP REPORTED WHILE PROCEDURE WAS IN PROGRESS. DETAILS TO BE PROVIDED AFTER PROCEDURE. ADDITIONAL INFORMATION OBTAINED 07/20/2020: PATIENT INITIALLY UNDERWENT A REVERS TOTAL SHOULDER PROCEDURE (B)(6) 2019. PATIENT BEGAN EXPERIENCING POST OP PAIN. AN X-RAY REVEALED A POSSIBLE LOOSENING OF THE GLENOID UNIT. A CT WAS PERFORMED TO CONFIRM. THE PATIENT SUFFERED NO KNOWN OR REPORTED TRAUMA. ON (B)(6) 2020 THE SAME SURGEON PERFORMED A REVISION AT A DIFFERENT FACILITY. DURING THE REVISION THE FOLLOWING ORIGINAL IMPLANTS WERE EXPLANTED: AR-9564-2433, GLENOSPHERE, LOT 18.01946, AR-9560-24, UNIVERS REVERS MODULAR BASEPLATE, LOT 7037/7041, AR-9501-05P, UNIVERS REVERS IMPLANT STEM MODULAR, LOT 19.00135, AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 19.02069, AR-9503-3633-3, HUMERAL INSERT, LOT 19.00009AR-9561-25S, MODULAR CENTRAL SCREW, LOT 6799, AR-9563-16 (QTY 3), LOCKING SCREW, LOT 19.00568/2019001684. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 10366791 ↗