Arthrex® AR-9564-2436Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867295667), received between Nov 14, 2022 and Mar 10, 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.

• MalfunctionMar 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 2/11/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A BONE FRACTURE IN THE TARGETED SHOULDER. ABOUT SEVEN MONTHS POST OPERATION, THE PATIENT MADE A QUICK TURN AROUND AND ENDED UP FRACTURING THE GLENOID CAVITY OF RIGHT SCAPULA. THIS WAS CONFIRMED VIA A CT SCAN ON (B)(6) 2024. THE PATIENTS PAIN BEGAN TO IMPROVE AS OF ON (B)(6) 2024. THE PATIENT REPORTED DECREASED RANGE OF MOTION ON (B)(6) 2024 AND SHARP PAIN ON (B)(6) 2025. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS SYSTEM IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 2/21/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD, AN AR-9501-04-135R UNIVERS REVERS STEM, AN AR-9503-3336-3 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2436 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLE

  Patient problems: Insufficient Information

  MAUDE report 21559742 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 7/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS DEVICES IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT STARTED TO EXPERIENCE PAIN. IT WAS SUSPECTED THE PATIENT SUFFERED AN ACROMIAL FRACTURE, WHICH WAS CONFIRMED IN APRIL VIA CT SCAN. THE PATIENT WAS IMMOBILIZED IN A SLING FOR SIX WEEKS. ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN; X-RAY IMAGES REVEALED A HEALED FRACTURE. THE PATIENT DID NOT SUFFER A FALL OR HAVE AN INJURY. THE PAIN BEGAN AFTER PHYSICAL THERAPY. THE IMPLANTS ARE NOT LOOSE OR BROKEN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19940382 ↗
• InjuryFeb 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9660-R CENTRAL POST EXTRACTOR GOT STUCK IN THE IMPLANT DURING IMPLANT REMOVAL. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/31/2024: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2021. DUE TO PAIN, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9503S-03 HUMERAL INSERT, AN AR-9555-09 UNIVERS REVERS SPACER, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AN AR-9563-24 PERIPHERAL LOCKING SCREW, AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9564-2436 GLENOSPHERE, AN AR-9580-2410-2 BASEPLATE, AND AN AR-9582-25 MODULAR POST WERE EXPLANTED. ONLY AN AR-9501-10S UNIVERS REVERS APEX STEM AND AN AR-9502F36RCPC SUTURE CUP REMAINED FROM THE ORIGINAL SURGERY. TO COMPLETE THE REVISION SURGERY, AN AR-9503S-03C HUMERAL INSERT, AN AR-9555-12 UNIVERS REVERS SPACER, AN AR-9560-24-4 BASEPLATE, AN AR-9561-30S CENTRAL SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, (2) AR-9563-28 PERIPHERAL LOCKING SCREW,

  Patient problems: Implant Pain

  MAUDE report 18695307 ↗
• InjuryNov 14, 2022Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A PRIMARY INSTALLATION OF AN INVERSE PROSTHESIS WITH MGS ON (B)(6) 2019. AS THE GLENOID COMPONENTS ARE NOT GROWN IN A REVISION SURGERY TOOK PLACE ON (B)(6) 2022. THE COMPLETE GLENOID WAS REMOVED: TOTAL GLENOID SIDE AND THE INLAY SHAFT SIDE. IMPLANTATION AND CONVERSION TO CTA WAS SUCCESSFUL, PATIENT IS PAIN-FREE. THE REMOVED IMPLANTS WERE NOT SENT FOR CLARIFICATION OF A POSSIBLE INFECTION/BACTERIA. ALL TISSUE ON THE IMPLANT WAS REMOVED. DURING REVISION SURGERY THE FOLLOWING DEVICES WERE ALSO REMOVED FROM PATIENT: 1X AR-9560-24P LOT: 5365. 1X AR-9562-24NL LOT: 18.00142. 1X AR-9562-32NL LOT: 18.00153. 1X AR-9563-24 LOT: 2019000255. 1X AR-9563-36 LOT: 18.01676. 1X AR-9503S-03 LOT: 19.00664.

  Patient problems: Failure of Implant

  MAUDE report 15788300 ↗