Arthrex® AR-9560-24-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867296473), received between Nov 16, 2021 and Dec 9, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE CONNECTION BETWEEN THE BASE PLATE AND THE BOLT BROKE. 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. FURTHER INFORMATION RECEIVED WITH A REGARDING CRM CASE: IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CONNECTION BETWEEN THE SCREW AND THE BASEPLATE IS BROKEN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT 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 23759249 ↗
• MalfunctionFeb 13, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9560-24-4 UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW, HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS SCREWING THE CENTRAL SCREW INTO THE GLENOID, THE CENTRAL SCREW DETACHED ON THE LAST TURN FROM THE BASEPLATE AND WAS STUCK IN THE PATIENT'S BONE. THE SCREW DID NOT BREAK AND WAS REMOVED FROM THE PATIENT'S BONE IN ONE PIECE, AND THE BASEPLATE WAS ALSO REMOVED. NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO HARM TO THE PATIENT. ANOTHER AR-9560-24-4 UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW, WITH DIFFERENT UNKNOWN LOT NUMBERS, WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A CASE DELAY OF UNDER 15 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377124 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 09/24/2024, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354718 ↗
• 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 INSERTER. 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 19510183 ↗
• MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24-4 BASEPLATE AND AN AR-9561-30S CENTRAL SCREW DISASSOCIATED FROM EACH OTHER DURING INSERTION. THIS WAS DISCOVERED DURING AN ARTHROPLASTY REVERSE SHOULDER PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED ON (B)(6) 2022. ADDITIONAL INFORMATION PROVIDED ON 08/05/2022: THE PATIENT HAD EXTREMELY HARD BONE. AN AR-9618-24 WAS USED OVER A 2.8MM GUIDE PIN. AFTER SUFFICIENT REAMING WITH PRIMARY GLENOID REAMER AN AR-9620-10D WAS DRILLED OVER 2.8 GUIDE PIN TO A POSITIVE STOP. ONCE DRILLING WAS COMPLETED AN AR-9621-30T, IN CONJUNCTION WITH THE MANUAL DRIVER SHAFT AR-9631 WAS INSERTED TO A POSITIVE STOP, THEN REMOVED. AFTER PREPARATION OF THE GLENOID WAS ACHIEVED THE MGS BASEPLATE WAS INSERTED WITH THE BASEPLATE INSERTER, THE AR-9623 THREADED. THE BASEPLATE DISASSOCIATED RIGHT BEFORE BACKSIDE SEATING OF THE BASEPLATE INTO THE PREPPED GLENOID SURFACE. THE CASE WAS COMPLETED BY USING A NEW AR-9560-24-4 LOT: 14939747 AND AR-9561-30S LOT: 14950583 WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080996 ↗
• MalfunctionApr 2, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN INVERSE SHOULDER PROSTHESIS SURGERY WITH MGS THE SURGEON EXPERIENCED ISSUES WITH THE SCREW AND THE PLATE. WHEN THE SURGEON MERGED THE BASEPLATE AND SCREW HE EXPERIENCED FIRST A RESISTANCE, THEN LOUD CRACKING. AFTER THAT THE SCREW COULD BE INSERTED COMPLETELY. ACCORDING TO THE SURGEON THE SCREW WAS SLIGHTLY TILTED AND THEREFORE NOT 100% STABLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19020793 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 3/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9560-24-4 BASEPLATE AND AN AR-9561-30S CENTRAL SCREW CAME APART DURING INSERTION. THIS WAS DISCOVERED DURING A REVERS TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. THE PRESS WAS USED TO PRESS DOWN BOTH DEVICES TOGETHER. THE PHYSICIAN ASSISTANT VERIFIED THAT IT WAS BETWEEN THE MINIMUM AND MAXIMUM. HOWEVER, WHEN THE SURGEON INSERTED THE BASEPLATE AND CENTRAL SCREW IN THE PATIENT, THEY CAME APART. THE SURGEON WAS NOT FAR INTO THE SURGERY YET AND WAS ABLE TO REMOVE THE BASEPLATE AND CENTRAL SCREW EASILY. THE SURGEON WAS NOT CONFIDENT IN THE INTEGRITY OF THE DEVICES AND DID NOT WANT TO TRY TO PUT THEM BACK TOGETHER AGAIN; INSTEAD, THE CASE WAS COMPLETED USING A NEW AR-9560-24-4 BASEPLATE AND AN AR-9561-30S CENTRAL SCREW. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914274 ↗
• InjuryFeb 7, 2022Fracture; Appropriate Device Problem Term/Code Not Available

  ON 01/18/2022, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO A DEEP INFECTION. THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2017 FOR A REVERSE TOTAL SHOULDER REPLACEMENT WERE A UNIVERS REVERS, GLENOSPHERE SIZE (36MM), GLENOSPHERE OFFSET (4MM LATERAL), STEM FIXATION (PRESSFIT), STEM SIZE (6), AND SUTURECUP (NEUTRAL) WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 01/20/2022: THE FIRST COMPLICATION WAS REPORTED ON (B)(6) 2018 FOR A SHOULDER INFECTION. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2019 FOR A REVERSE ARTHROPLASTY WITH REMOVAL OF ANTIBIOTIC SPACER. THIS PROCEDURE TOOK PLACE AT (B)(6) HOSPITAL, ARTHREX ACCOUNT #: (B)(4) WERE AN AR-9560-24-4 AND AN AR-9561-25S WAS EXPLANTED. DEVICE(S) WERE DISCARDED. A SECOND COMPLICATION WAS REPORTED ON (B)(6) 2019 DUE TO A PATIENT FALL, RESULTING IN A PERIPROSTHETIC FRACTURE. THIS COMPLICATION WAS TREATED WITH A BRACE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 13471336 ↗
• 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

  MAUDE report 12819063 ↗