Arthrex® AR-9501-10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867250512), received between Oct 30, 2020 and Mar 4, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.

• InjuryMar 4, 2026Patient Device Interaction Problem

  ON 28-JAN-2026, THE PATIENT REPORTED VIA EMAIL THAT, FOLLOWING A REVERSE TOTAL SHOULDER SURGERY, THEY EXPERIENCED INCREASING POSTOPERATIVE PAIN. X-RAYS REPORTEDLY SHOWED A BROKEN SCREW, AND A CT SCAN DEMONSTRATED A LOOSE IMPLANT. THE PATIENT IS NOW SCHEDULED FOR A CORRECTIVE SURGICAL PROCEDURE. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 09-FEB-2026: THE PATIENT IS SCHEDULED TO UNDERGO A REVISION LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2026. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. OVER TIME, THE PATIENT DEVELOPED SIGNIFICANT LEFT SHOULDER PAIN. THE PATIENT¿S SPOUSE REPORTED PROGRESSIVE DISCOMFORT IN THE PATIENT¿S LEFT ARM. DIAGNOSTIC IMAGING WAS PERFORMED, INCLUDING AN X-RAY ON (B)(6) 2025, WHICH IDENTIFIED A FRACTURED SCREW, FOLLOWED BY A CT SCAN ON (B)(6) 2025 THAT DEMONSTRATED LOOSENING OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON 10-FEB-2026: THE PATIENT'S SPOUSE REPORTED THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ALL COMPONENTS OF THE LEFT SHOULDER WERE R

  Patient problems: Discomfort; Pain

  MAUDE report 24512359 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/8/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A SUBLUXATION, WHICH RESULTED IN A REVISION OF THE COMPONENTS ON (B)(6) 2023. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/25/2025 VIA CLINDEX NOTIFICATION: ON (B)(6) 2023, THE PATIENT REPORTED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT RETURNED AND REPORTED DIFFICULTY WITH RAISING THE ARM ALONG WITH CONTINUED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2025. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9580-2420-2 UNIVERS REVERS AUGMENTED BASEPLATE, AN AR-9501-10S UNIVERS REVERS APEX HUMERAL STEM, AND AN AR-9503S-03 ARTHREX UNIVERS REVERS HUMERAL INSERT WERE EXPLANTED. THE CASE WAS COMPLETED USING A NEW GLENOSPHERE, A HUMERAL INSERT, A SPACER, AND A BASEPLATE.

  Patient problems: Pain

  MAUDE report 21664249 ↗
• InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION AND LOOSENED BASEPLATE. IN JUNE 2023, THE PATIENT COMPLAINED OF PAIN AFTER THE ORIGINAL PROCEDURE ON (B)(6) 20203. DURING THE POST-OPERATIVE VISIT, RADIOGRAPHS INDICATED A LOOSENED BASEPLATE, BUT THE INFECTION TYPE WAS NOT YET CONFIRMED. DURING THE REVISION SURGERY, AN AR-9564-2433-LAT GLENOSPHERE, AN AR-9580-2420 BASEPLATE, AN AR-9582-20 MODULAR POST, AN AR-9501-10S HUMERAL STEM, AN AR-9502F-33CPC SUTURE CUP, AN AR-9503XS-03 HUMERAL INSERT, AN AR-9504-06 HUMERAL SPACER, AN AR-9562-24NL PERIPHERAL NON-LOCKING SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AND AR-9563-24 PERIPHERAL LOCKING SCREW WERE EXPLANTED. THE CASE WAS COMPLETED BY TAKING CULTURES FOR FURTHER TESTING AND PLACING ANTIBIOTIC SPACERS. NO ADDITIONAL ARTHREX PRODUCTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17363922 ↗
• InjuryOct 30, 2020Patient-Device Incompatibility

  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 10763672 ↗