Arthrex® AR-9501-08PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867250406), received between May 6, 2020 and Jun 25, 2024 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON MAY 1ST, 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A SEVERE COMPLICATION OCCURRED, RESULTING IN REVISION SURGERY TO A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023 WITH CTA HEAD AND GLENOID GRAFTING. ADDITIONAL INFORMATION RECEIVED ON 5/16/2024. THE ORIGINAL TSA PROCEDURE WAS PERFORMED ON (B)(6) 2009. THE IMPLANTS USED IN THE ORIGINAL PROCEDURE WERE PRODUCTS FROM ANOTHER MANUFACTURING COMPANY. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE SURGEON DUE TO SEVERAL YEARS OF PAIN, AND IT WAS CONFIRMED VIA CT ARTHROGRAM THAT THE IMPLANTS HAD LOOSENED, AND THE PATIENT HAD SEVERAL ROTATOR CUFF TEARS. ON (B)(6) 2023, THE PATIENT WAS REVISED FROM A TSA TO A HEMIARTHROPLASTY IN WHICH THE SURGEON IMPLANTED A CTA HEAD AND GLENOID BONE GRAFT. SOON AFTER THE SURGERY, THE PATIENT STILL EXPERIENCED PAIN AND THE SURGEON SUGGESTED THE PATIENT MIGHT BE A CANDIDATE FOR A STATE PROCEDURE TO PUT IN A BASEPLATE. ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY TO CONVERT THE HEMIARTHROPLASTY TO A REVERS TSA WITH A REPLANT OF THE GLENOID BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 5/29/2024: DURING THE REVISION

  Patient problems: Pain

  MAUDE report 19605763 ↗
• InjuryFeb 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/9/2024, IT WAS REPORTED ON CASE NUMBER (B)(4) 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)(4). 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 A

  Patient problems: Unspecified Infection

  MAUDE report 18623994 ↗
• InjuryMay 6, 2020Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED DURING A REVISION REVERSE SHOULDER TO A CLOSED REDUCTION PROCEDURE ON (B)(6) 2020, THE SURGEON WAS CHECKING IF THE PERIPHERAL SCREWS OF THE 24MM +2 MGS BASEPLATE WERE LOOSE. WHEN THE SURGEON TIGHTENED THE SCREWS, THE BLUE HANDLE OF THE AR-1999HH, RATCHETING HANDLE WAS CLICKING AND DID NOT HAVE A POSITIVE STOP. THE SURGEON DETERMINED THAT THE MGS BASEPLATE WAS LOOSE, SO THEY PROCEEDED TO EXPLANT THE SCREWS AND BASEPLATE WITHOUT ANY ISSUES. THE MGS BASEPLATE WAS IMPLANTED PRIOR TO THE REVISION SURGERY. THE IMPLANTS WERE CONVERTED TO TORNIER. AT THE TIME OF INITIAL REPORT TO ARTHREX NO FURTHER DETAILS WERE AVAILABLE. ADDITIONAL INFORMATION OBTAINED 4/13/2020 AND 4/15/2020: THE INITIAL REPORT PROVIDED WAS NOT A COMPLETE DESCRIPTION AND FURTHER, MORE DETAILED, INFORMATION HAS BEEN OBTAINED TO CLARIFY THE ENTIRE PATIENT RELATED EVENTS. THE FEMALE PATIENT UNDERWENT A PRIMARY REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A FALL (DATE UNKNOWN) WHICH RESULTED IN A PERIPROSTHETIC HUMERAL FRACTURE. THE PATIENT UNDERWENT A FIRST REVISION ON (B)(6) 2020 WHERE THE SURGEON EXPLANTED THE FOLLOWING DEVICES AND REPLACED THEM WITH ANOTHE

  Patient problems: Fall

  MAUDE report 10028430 ↗