Arthrex® AR-9561-35SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867296589), received between Nov 2, 2021 and Dec 11, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9561-35S TAPS TIP BROKE WITHIN THE PATIENT, THE SURGEON COMPLETED THE CASE AFTER CHANGING HIS PLAN BY CHANGING THE LENGTH OF THE CENTRAL FIXATION SCREW (MODULAR GLENOID CENTRAL SCREW). ALL FRAGMENTS OF THE TAP WERE ABLE TO BE REMOVED. THIS OCCURRED DURING USE IN A REVERSE TSA CASE WITH NO PATIENT EFFECT. THERE WAS NO ADDITIONAL TIME ADDED TO THE CASE AND NO ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780050 ↗
• MalfunctionFeb 21, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE AND AN AR-9561-35S UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL SCREW FELL APART ONCE IMPLANTED. THE SURGEON USED A SCREWDRIVER TO REMOVE THE IMPLANTS FROM THE PATIENT. THE CASE WAS COMPLETED USING A NEW BASEPLATE AND CENTRAL SCREW. THIS WAS DISCOVERED DURING A REVERS SHOULDER PROCEDURE ON (B)(6) 2025. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434730 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 9/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-35S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW, AND AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE DISASSOCIATED DURING FINAL TIGHTENING IN THE GLENOID. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/30/2024: THE CENTRAL SCREW AND BASEPLATE DISASSOCIATED WHILE IN THE PATIENT'S GLENOID; EVERYTHING WAS REMOVED. THE CASE WAS COMPLETED USING A NEW AR-9561-35S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW, AND AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE. THE CASE DELAYED FIVE MINUTES OF LESS WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20385671 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-35S UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL SCREW AND AN AR-9560-24-4 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE CAME APART. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 9/26/2024: THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2024. THE IMPLANTS WERE INSERTED IN THE PATIENT AND REMOVED BECAUSE THEY WERE NOT FLUSHED. THE SURGEON RE-TAPPED AND REINSERTED THE IMPLANTS. ONCE REINSERTED, THERE WAS NO BITE, AND THE IMPLANTS CAME APART. EVERYTHING WAS REMOVED FROM THE PATIENT, AND NEW IMPLANTS WERE USED TO COMPLETE THE CASE. THE CASE WAS DELAYED LONG ENOUGH TO OPEN NEW IMPLANTS AFTER REMOVING THE CENTER SCREW FROM THE PATIENT'S GLENOID. ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354552 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 4/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24-4 MODULAS BASEPLATE BECAME DISENGAGED FROM AN AR-9561-35S CENTRAL SCREW WHEN THE FIRST AR-9563-36 PERIPHERAL SCREW WAS INSERTED. THE HEAD OF THE AR-9563-36 PERIPHERAL SCREW WAS STRIPPED. THE SURGEON REMOVED EVERYTHING FROM INSIDE THE PATIENT AND OPENED A NEW AR-9560-24-4 MODULAS BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AN AR-9563-36 PERIPHERAL SCREW TO COMPLETE THE CASE. THE SURGEON ENSURED THE CENTRAL SCREW WAS WELL SEATED ON THE BASEPLATE WHILE ON THE BACK TABLE BEFORE IMPLANTING THE NEW PRODUCTS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 5/1/2023: THIS WAS DISCOVERED DURING AN RTS AND COMPLETED WITH ANOTHER AR-9560-24-4 MODULAS BASEPLATE, AR-9561-35S CENTRAL SCREW, AND AR-9563-36 PERIPHERAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510150 ↗
• MalfunctionMay 21, 2024Unintended Movement; Unintended Movement

  ON 06/01/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9560-24-4 24MM +4 LAT BASEPLATE AND AN AR-9561-35S CENTRAL SCREW WERE DAMAGED, THE SURGEON WOULD NOT USE THEM. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 06/13/2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE. THE IMPLANT WAS PROPERLY COMPRESSED AND THE MORSE TAPER ENGAGED PRIOR TO INSERTING, THE IMPLANT WAS THEN PLACED ON THE INSERTER AND AS HE WAS TIGHTENING THE BASEPLATE AND MAKING HIS FINAL TURN THE ACTUAL BASEPLATE BECOME DISENGAGED FROM THE CENTRAL SCREW PORTION. THE CENTRAL SCREW SEATED PROPERLY BEFORE PRESSING AND THE SURGEON SHOWED THE SALES REPRESENTATIVE THE LINE BETWEEN MIN AND MAX ON THE PRESS BEFORE RELEASING, THEN INSERTING. THEY WERE INSERTING INTO THE GLENOID AND IT WAS HARD BONE BUT THE PROPER IMPLANTATION STEPS WERE MADE PRIOR TO IMPLANTING. PROPER TECHNIQUE STEPS WERE DONE TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT, PIN PLACED, BASEPLATE REAMER USED, PERIPHERAL REAMER WAS USED, THE 10MM OPENING DRILL WAS DRILLED TO THE PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359222 ↗
• MalfunctionOct 30, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-35S CENTRAL SCREW AND AN AR-9560-24-2 BASEPLATE DISCONNECTED. AFTER SETTING THE IMPLANTS IN THE COMPRESSOR, IT STARTED TO MAKE NOISE WHEN SPINNING IT DOWN. THE TECHNICIAN IMMEDIATELY STOPPED ONCE THE NOISE WAS HEARD AND CHECKED TO SEE IF THE BASEPLATE AND SCREW WERE BEING LINED UP IN ASSOCIATION WITH THE COMPRESSOR. ANOTHER ATTEMPT WAS MADE, BUT THE COMPRESSOR CONTINUED TO MAKE NOISE. AFTER THE MIDLINE WAS PASSED, THE TECHNICIAN TESTED TO SEE IF THE BASEPLATE AND SCREW WERE ENGAGED, WHICH THEY WERE. DURING THE LAST COUPLE OF TURNS OF PUTTING IN THE SCREW, IT DISCONNECTED FROM THE BASEPLATE. THE CASE WAS COMPLETED BY REMOVING THE SCREW AND THE BASEPLATE AND USING NEW ONES. THIS WAS DISCOVERED DURING A RTS PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18032201 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9501-06P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503S-03 HUMERAL INSERT, AN AR-9564-2436-LAT GLENOSPHERE, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, (2)AR-9563-28 PERIPHERAL SCREW, AND (2) AR-9563-20 PERIPHERAL SCREW, WERE EXPLANTED DURING A REVISION SHOULDER ARTHROPLASTY SURGERY ON (B)(6) 2023. ON (B)(6) 2022, THE PATIENT UNDERWENT ORIGINAL SURGERY. THEN IN (B)(6) 2023, THE PATIENT STARTED TO EXPERIENCE PAIN. RADIOGRAPHS APPEARED TO SHOW SOME RADIOLUCENT LINES AROUND THE BASEPLATE. THE PATIENT DID NOT REPORT ANY FALLS OR NOTABLE EVENTS. THE INFECTION TYPE HAS NOT BEEN CONFIRMED. DURING THE REVISION SURGERY, AN AR-9150-21 CA HUMERAL HEAD AND AN AR-9100-05P MONOBLOCK STEM WERE IMPLANTED AS FUNCTIONAL ANTIBIOTIC SPACERS. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON BUT AT DIFFERENT FACILITIES.

  Patient problems: Unspecified Infection

  MAUDE report 17112033 ↗
• MalfunctionFeb 16, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9560-24-2 BASEPLATE AND AN AR-9561-35S CENTRAL SCREW HAD AN ISSUE. DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS INSERTING THE BASEPLATE WITH THE SCREW INSIDE THE PATIENT, THE SCREW BROKE OFF THE BASEPLATE INTO THE GLENOID. BOTH DEVICES WERE REMOVED FROM THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. ANOTHER BASEPLATE AR-9560-24-4 WITH LOT NUMBER 15030027 AND ANOTHER SCREW AR-9561-30S WITH LOT # 14977751 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. BOTH DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386020 ↗
• MalfunctionOct 17, 2022Break

  ON 9/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN A PATIENT UNDERWENT A REVERSE MODULAR SHOULDER PROCEDURE ON (B)(6) 2020. DURING THIS PROCEDURE AN AR-9501-13S APEX HUMERAL STEM, AN AR-9502F-39LCPC SUTURE CUP, AN AR-9503M-03 HUMERAL INSERT, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AN AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE, WERE SUCCESSFULLY IMPLANTED. TWO YEARS LATER, ON (B)(6) 2022, PATIENT UNDERWENT A REVISION REVERSE TOTAL SHOULDER PROCEDURE BECAUSE THE CENTRAL AND PERIPHERAL SCREWS BROKE OFF THE BASEPLATE. ADDITIONAL INFORMATION RECEIVED ON 9/30/2022: DURING REVISION SURGERY ON (B)(6) 2022, AN AR-9560-28-4 MODULAR BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AN AR-9563-36 PERIPHERAL LOCKING SCREW, AND AR-9563-40 PERIPHERAL LOCKING SCREW, AND AN AR-9564-2839-LAT GLENOSPHERE WERE REMOVED. PROCEDURE WAS COMPLETED BY IMPLANTING AN AR-9502-39ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER FROM LOT NUMBER 18.00756 AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD FROM LOT NUMBER 10248799 WERE IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15615556 ↗
• MalfunctionNov 16, 2021Break

  ON 10/29/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9560-24-4 AND AR-9561-35S BASEPLATE BROKE OFF, LEAVING SCREW INSIDE OF THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-9560-24-4 AND AR-9561-35S. ADDITIONAL INFORMATION PROVIDED 10/29/2021: PROCEDURE BEING PERFORMED WAS A REVERSE TOTAL SHOULDER. THE BROKEN SCREW WAS REMOVED FROM THE PATIENT. BONE QUALITY OF THE PATIENT WAS GOOD. THE 35MM TAP WAS USED TO PREPARE THE BONE SOCKET. THE CASE WAS COMPLETED BY USING THE 4.0 HEX DRIVER FROM MGS 2 TO REMOVE THE SCREW. WE OPENED A NEW BASEPLATE AND CENTRAL SCREW (DOWNSIZED TO 30MM) AND WERE ABLE TO SUCCESSFULLY COMPLETE THE CASE.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 12819073 ↗
• MalfunctionNov 2, 2021Material Separation

  ON 10/11/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS USING AN AR-9622 TAPER ASSEMBLY PRESS WAS USED TO PAIR THE AR-9560-28-2, 28MM +2 LAT. MGS BASEPLATE AND AR-9561-35S, 35MM CENTRAL SCREW, BUT UPON INSERTION THE BASEPLATE AND CENTRAL SCREW DISASSOCIATED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2021. THE CASE WAS COMPLETED BY REMOVING THE CENTRAL SCREW FROM THE GLENOID WITH REMOVAL DRIVER AND THEN OPENED NEW IMPLANTS WITH NO PATIENT HARM.

  Patient problems: Failure of Implant

  MAUDE report 12737421 ↗