Arthrex® AR-9561-30SRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867296572), received between Jul 22, 2020 and Jul 9, 2025 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AFTER BUILDING AN MGS BASEPLATE AND CENTRAL SCREW, THE BASEPLATE WOULD NOT CONNECT TO THE INSERTER. IT APPEARS THAT THE BASEPLATE DOES NOT HAVE THE THREADS IN THE CENTRAL HUB, AS USUAL, MAKING IT IMPOSSIBLE FOR THE INSERTER TO THREAD INTO THE BASEPLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 06/25/2025: THIS OCCURRED DURING AN RTSA REVISION PROCEDURE ON (B)(6) 2025. THE INSERTER USED IN THE CASE WAS THE AR-9623 BASEPLATE INSERTER. THE CASE WAS COMPLETED BY OPENING A NEW BASEPLATE AND CENTRAL SCREW, AR-9560-24-2 24MM +2 LAT BASEPLATE, MODULAR (LOT: 15400885) AND AR-9561-30S 30MM CENTRAL SCREW, MODULAR (LOT: 15405212). THE CASE WAS DELAYED FIVE MINUTES, AND WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED IS UNCERTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462188 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 06/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9560-24 BASEPLATE 24 MM AND AN AR-9561-30S CENTRAL SCREW 30 MM WERE BEING IMPLANTED WHEN THE SCREW DISASSOCIATED FROM THE BASEPLATE. BEFORE PRESSING THE TWO IMPLANTS TOGETHER IT WAS CONFIRMED THAT THE SCREW WAS CORRECTLY SEATED ONTO THE BASEPLATE, AND THE COMPONENTS WERE PRESSED TOGETHER PROPERLY. DURING IMPLANTATION, THEY ATTEMPTED AN ADJUSTMENT, AND WHEN THE BASEPLATE CAME OUT, THE SCREW STAYED IN. BOTH COMPONENTS APPEARED STRIPPED. THE CASE WAS COMPLETED, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/27/2025: DURING THE PROCEDURE, THE SCREW AND BASEPLATE APPEARED TO DISASSOCIATE WHILE BEING IMPLANTED. BOTH COMPONENTS WERE SUCCESSFULLY EXTRACTED USING THE APPROPRIATE REMOVAL INSTRUMENTS, AND THE CASE PROCEEDED WITHOUT COMPLICATION. THE BASEPLATE WAS REPLACED WITH PART NUMBER: AR-9560-24, AND THE SCREW WAS REPLACED WITH PART NUMBER: AR-9561-30S. THERE WAS A MINIMAL CASE DELAY AND A LIMITED TIME REQUIRED TO REMOVE AND REPLACE THE COMPONENTS. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455770 ↗
• MalfunctionApr 28, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 4/2/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24-2 ARTHREX UNIVERS REVERS BASEPLATE AND AN AR-9561-30S ARTHREX UNIVERS REVERS CENTRAL SCREW FAILED TO PROPERLY MATE AFTER BEING PRESSED TOGETHER WHILE ON THE BACK TABLE. WHEN ATTEMPTING IMPLANTATION, THE BASEPLATE REPEATEDLY DISENGAGED FROM THE SCREW AND SEPARATED. THIS RESULTED IN THE INABILITY TO USE THE ITEMS AS INTENDED. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2025.

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

  MAUDE report 21917638 ↗
• MalfunctionFeb 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 21376818 ↗
• MalfunctionJun 7, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED ON 08/05/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-30S AND AR-9560-24 SCREW AND BASEPLATE WOULD NOT FIT TOGETHER AND WERE STRIPPED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491801 ↗
• MalfunctionApr 12, 2024Defective Device; Defective Device

  ON 12/13/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-4 BASEPLATE AND AN AR-9561-30S CENTRAL SCREW WERE NOT IMPLANTED CORRECTLY BECAUSE THE MORSE TAPER FELL APART. THIS WAS DISCOVERED DURING A PROCEDURE. SURGEON COMPLETED CASE SUCCESSFULLY WITHOUT FURTHER ISSUE BY USING A NEW BASEPLATE AND CENTRAL SCREW. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/14/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT CASE WAS COMPLETED USING AN AR-9560-24 FROM LOT NUMBER 12732669 AND AN AR-9561-30S FROM LOT NUMBER 9549. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097244 ↗
• MalfunctionApr 11, 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 19089619 ↗
• InjuryApr 8, 2024Break; Break

  ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 CAME LOOSE FROM THE SUTURECUP AND COULD NOT BE SEPARATED. THE TRIAL CA ADAPTER WAS PLACED IN THE SUTURECUP AND THE TRIAL CA HEAD WAS PLACED. AN X-RAY WAS TAKEN, AND IT WAS DETERMINED THAT THE CA HEAD WAS THE APPROPRIATE SIZE. THE TRIALS WERE REMOVED. THE STEM/CUP IMPACTOR HANDLE WAS THREADED INTO THE CA ADAPTER. THE TAB OF THE CA ADAPTER WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. THE IMPLANT WAS IMPACTED INTO THE SUTURECUP. THE CA HEAD WAS IMPACTED WITH THE GLENOSPHERE IMPACTOR MAKING SURE THE HOOD OF THE HEAD WAS LATERAL. THE CA ADAPTER CAME LOOSE FROM SUTURECUP. THE SURGEON ASKED FOR A NEW CA ADAPTER AND A CA HEAD AS THEY COULD NOT BE SEPARATED. A SECOND AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER WAS PLACED ON THE IMPACTOR HANDLE AND WAS IMPACTED INTO THE SUTURECUP. THE GLENOSPHERE IMPACTOR WAS USED AS WELL TO SEAT THE ADAPTER INTO THE SUTURECUP BUT WITH LITTLE EFFORT, THE CA ADAPTER COULD BE PULLED FROM THE SUTURECUP. THE SURGEON WAS ABLE TO SEPARATE THE FIRST SET OF IMPLANTS AND TRIED AGAIN TO IMPACT THE CA ADAPTER INTO THE SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19062834 ↗
• MalfunctionApr 5, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN UNIVERS REVERS MGS SURGERY SCREW WHICH IS PRESSED INTO THE PLATE DID NOT HOLD. 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 19055896 ↗
• 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 19021004 ↗
• MalfunctionMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24 UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE, AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM CENTRAL SCREW, DISSOCIATED DURING IMPLANTATION. ON THE ASSEMBLY PRESS, PROPER HEX ALIGNMENT BETWEEN BASEPLATE AND CENTRAL SCREW WAS FOUND VIA GENTLE ROTATION OF SCREW UNTIL IT FELL FLUSH TO THE BACK OF THE BASEPLATE. THE BASEPLATE WAS ALIGNED ON THE CORRECT SMALL/LARGE PEGS. THE PRESS WAS CRANKED DOWN/PRESSURED THE MORSE TAPE TOGETHER UNTIL THE LASER LINE WAS BETWEEN MIN/MAX. IMPLANT WAS THREADED ONTO INSERTER AND PLACED INTO GLENOID. DURING ROTATION OF SCREWING THE IMPLANT INTO GLENOID, THE BASEPLATE POPPED OFF THE CENTRAL SCREW, LEAVING THE SCREW IN THE GLENOID. IT WAS REMOVED CLEANLY WITH THE HEX DRIVER FROM THE MGS 2 TRAY. ADDITIONAL INFORMATION RECEIVED ON 5/23/2022: CASE WAS COMPLETED USING A NEW BASEPLATE AND CENTRAL SCREW, NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19008454 ↗
• MalfunctionMar 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A UNIVERS REVERS SURGERY WITH A MODULAR GLENOID SYSTEM THE BASEPLATE AND CENTRAL SCREW WERE DISLOCATED DURING IMPLANTATION. THE BASEPLATE AND CENTRAL SCREW WERE ASSEMBLED CORRECTLY. THE BASEPLATE WAS SEATED CORRECTLY ON THE PRESS, THE CENTRAL SCREW WAS PLACED CORRECTLY (PLACED, ROTATED UNTIL THE HEX PIN ENGAGES AND THERE IS NO LONGER A VISIBLE GAP BETWEEN THE BASEPLATE AND CENTRAL SCREW) AND TIGHTENED CORRECTLY UNTIL THE DISPLAY SHOWS BETWEEN THE MIN AND MAX MARKINGS. WHEN IMPLANTING THE BASEPLATE AND CENTRAL SCREW, THE BASEPLATE COULD NOT BE SCREWED IN SUFFICIENTLY DUE TO HARD BONE SO THAT THE BACK OF THE BASEPLATE LAID ON THE GLENOID WITH SATISFACTORY COMPRESSION. THE SURGEON THEN TRIED TO TIGHTEN THE BASEPLATE FURTHER USING THE BASEPLATE EXTRACTOR AND BASEPLATE EXTRACTOR WRENCH, BUT THE BASEPLATE BECAME DETACHED FROM THE CENTRAL SCREW. THE CENTRAL SCREW REMAINED IN THE GLENOID AND COULD BE REMOVED BY USING A 4MM HEX DRIVER. THE THREAD WAS THEN RECUT WITH THE THREAD CUTTER AND A NEW BASEPLATE WITH A NEW CENTRAL SCREW WAS INSERTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944660 ↗
• 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 18914252 ↗
• MalfunctionFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW, MODULAR 30 MM DISASSOCIATED FROM THE BASEPLATE WHEN BEING IMPLANTED. NOTHING BROKE INSIDE THE PATIENT, AND THE SCREW WAS RETRIEVED FROM THE PATIENT. ANOTHER AR-9561-30S CENTRAL SCREW WAS USED TO COMPLETE THE CASE. THERE WAS A 30-MINUTE DELAY IN THE PROCEDURE, WITH ADDITIONAL ANESTHESIA ADMINISTERED DUE TO GETTING THE AR-9561-30S CENTRAL SCREW FROM ANOTHER FACILITY. THIS WAS DISCOVERED DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18760278 ↗
• MalfunctionFeb 6, 2024Damaged Thread; Damaged Thread

  ON 01/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM MODULAS BASEPLATE 24 MM +2 LAT AND AN AR-9561-30S UNIVERS REVERS MODULAR GLENOID SYSTEM, CENTRAL SCREW MODULAR 30 MM COLD-WELDED TOGETHER ON THE PRESS. WHEN SEPARATING THE MODULAR GLENOID SYSTEM MODULAS BASEPLATE FROM THE SCREW, IT STRIPPED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18649146 ↗
• MalfunctionJan 9, 2024Positioning Failure; Compatibility Problem; Positioning Failure; Compatibility Problem

  ON 12/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-9561-30S UNIVERS REVERS¿ MODULAR GLENOID SYSTEM HAD AN ISSUE MARRYING THE CENTRAL SCREW TO THE AR-9560-24-2 BASE PLATE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2023, WHERE THE CENTRAL SCREW DID NOT MARRY TO THE BASE PLATE, AND THE METAL ENDED UP GETTING A LITTLE DEFORMED. THEY FOLLOWED ALL THE CORRECT STEPS FROM THE TECHNIQUE GUIDE AND MADE SURE THE SCREW MARRIED THE BASE PLATE CORRECTLY BEFORE TIGHTENING DOWN WITH THE CLAMP. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18477995 ↗
• MalfunctionJul 6, 2023Break; Break

  ON 6/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A MORSE TAPER BROKE AND THE AR-9560-24-2 BASEPLATE AND AR-9561-30S CENTRAL SCREW DISSOCIATED. THE BASEPLATE CAME OUT ON THE INSERTER, AND THE CENTRAL SCREW WAS REMOVED USING THE EXTRACTION TOOL. THE CASE WAS COMPLETED SUCCESSFULLY USING A NEW AR-9560-24-2 BASEPLATE AND AR-9561-30S CENTRAL SCREW. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/12/2023: ALL THE BROKEN FRAGMENTS WERE REMOVED USING EXTRACTION TOOLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266908 ↗
• MalfunctionMay 16, 2022Break

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO A PROSTHETIC JOINT IMPLANT FAILURE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A SUPSCAP REPAIR SHOULDER ARTHROPLASTY. UPDATE: (B)(6) 2022: THE CENTRAL SCREW AND ONE PERIPHERAL SCREW HAD BROKEN AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO THE LOOSENING OF THE BASEPLATE. THE PROBLEM WAS IDENTIFIED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 14407316 ↗
• MalfunctionJul 20, 2021Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS SCREWING IN THE BASEPLATE AND THE SCREW, THE BASEPLATE BECOME DISENGAGED AND LOOKED AS IF IT SHEARED OFF SOME OF THE SCREW. THE SURGEON WAS ABLE TO REMOVE ALL PARTS BUT HAD TO USE A NEW BASEPLATE AND SCREW. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198358 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVERSE SHOULDER CASE DONE IN (B)(6) 2020. DUE TO INFECTIONS, ALL THE DEVICES WERE REMOVED ON (B)(6) 2021. AN ANTIBIOTIC SPACER WAS PLACED AT THE SITE; THERE MAY BE A SHOULDER REVISION DONE IN THE FUTURE. REMOVED AR-9501-05P, AR-9502F-36RCPC, AR-9564-2433-LAT, AR-9503-3633-3C, AR-9560-24, AR-9561-30S.

  Patient problems: Unspecified Infection

  MAUDE report 11872021 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION 11/16/20: WHEN THE EXPLANTED PRODUCTS WERE RETURNED FOR EVALUATION THE ORIGINAL HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP, AR-9503M-06 (LOT 18.00568) WAS ALSO RETURNED. IT WAS NOT INCLUDED IN THE ORIGINAL LIST OF EXPLANTED PRODUCTS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 10747389 ↗
• InjuryJul 22, 2020Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT THE MODULAR GLENOID SYSTEM WAS ASSEMBLED AND PRESSED TOGETHER WITH THE PRESS. DURING A REVERSE SHOULDER ARTHROPLASTY THE SURGEON HAS INSERTED THE GLENOID SYSTEM WITH THE CENTRAL SCREW AND WITH THE LAST TURN INTO THE GLENOID A "CLICKING" NOISE WAS RECOGNIZED AND THE CENTRAL SCREW BECAME DETACHED FROM THE BASE PLATE. THE CENTRAL SCREW WAS TOTALLY SCREWED IN THE GLENOID THEREFORE THE SURGEON DECIDED TO LEFT THE SCREW INSIDE THE GLENOID. THE SURGEON ATTACHED THE SAME BASE PLATE ONTO THE CENTRAL SCREW INSIDE THE PATIENT AND FIXATED THE PLATE WITH FOUR PERIPHERAL NON LOCKING SCREWS TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308301 ↗