Arthrex® AR-9561-20SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867296558), received between May 6, 2020 and Feb 25, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INVERSE SHOULDER PROSTHESIS SURGERY WITH MGS THE THREAD OF THE GLENOSPHERE SCREW DID NOT HOLD INSIDE THE BASE PLATE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458782 ↗
• MalfunctionMay 23, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-20S UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL SCREW DID NOT ACQUIRE THE PURCHASE ON AN AR-9560-24 UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE. THEY FUSED TOGETHER WHEN ATTEMPTING TO REMOVE THE CENTRAL SCREW, SO THE SURGEON HAS TO REMOVE THE BASEPLATE AS WELL. THE CASE WAS COMPLETED WITH A DIFFERENT BASEPLATE AND CENTRAL SCREWS. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/29/2024: THE PROCEDURE WAS COMPLETED USING A NEW AR-9560-24 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW. THE CASE WAS DELAYED AS THE SURGEON HAD TO REMOVE THE FAULTY IMPLANTS AND INSERT THE NEW ONES.

  Patient problems: Insufficient Information

  MAUDE report 19380308 ↗
• MalfunctionMay 14, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO ENGAGE THE MORRIS TAPER ON THE SCREW. TRIED MULTIPLE TIMES AND IT WOULD NOT ENGAGE. OPENED A SECOND SCREW AND IT WORKED CORRECTLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. SEE SOURCE DATA ATTACHED.

  Patient problems: Insufficient Information

  MAUDE report 19312533 ↗
• 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 AS G

  Patient problems: Unspecified Infection

  MAUDE report 18622791 ↗
• InjuryJun 2, 2022Unstable; Naturally Worn

  ON 5/4/2022, 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 5/12/2022: 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 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 7/17/2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCREW, AR-956

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

  MAUDE report 14573497 ↗
• MalfunctionJun 1, 2021Break

  IT WAS REPORTED, DURING A REVERSE TOTAL SHOULDER AS THE SURGEON WAS INSERTING THE AR-9560-24, PLATE, THE AR-9561-20S SCREW CAME OFF FROM THE PLATE, THE SCREW WAS IN THE PATIENTS GLENOID AND THE PLATE BECAME DISENGAGED. THE BROKEN PLATE AND SCREW WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED BY OPENED A SECOND AR-9560-24 AND AR-9561-20S, NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11912191 ↗
• InjuryMay 24, 2021Break

  IT WAS REPORTED THAT A REVERSE TOTAL SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCT WAS EXPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.02550), AR-9503-3633-3 (LOT: 19.00009), AR-9560-24-2 (LOT: 6364), AR-9561-20S (LOT: 7039), AR-9562-36NL (LOT: 18.01681 / THIS SCREW WAS BROKEN), AR-9563-20 (LOT: 19.00617), AR-9563-24 (LOT: 2018005452), AR-9564-2433-LAT (LOT: 19.00014). THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE REVISION SURGERY; AR-9502F-36CPC (LOT: 19.04723) AND AR-9503S-03C (LOT: 19.00504).

  Patient problems: Insufficient Information

  MAUDE report 11872361 ↗
• InjuryMay 6, 2020Fracture; Loose or Intermittent Connection

  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 10/8/19. 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 3/5/20 WHERE THE SURGEON EXPLANTED THE FOLLOWING DEVICES AND REPLACED THEM WITH ANOTHER MANUFAC

  Patient problems: Failure of Implant; Fall; No Code Available

  MAUDE report 10028404 ↗