Arthrex® AR-9560-24-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867296497), received between May 6, 2020 and Dec 19, 2025 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break; Break

  ON 11/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9560-24-2 TAP BROKE, THE SURGEON COMPLETED THE CASE AFTER CHANGING THE IMPLANT CHOICE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848528 ↗
• MalfunctionJul 23, 2025Component Missing; Component Missing

  ON 06/25/2025, AN ARTHREX EMPLOYEE REPORTED VIA EMAIL THAT AN AR-9560-24-2 24MM +2 LAT BASEPLATE EXHIBITED AN ISSUE IN WHICH THE CENTRAL FEATURE INTENDED FOR THE GLENOSPHERE SCREW WAS NOT THREADED. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22578027 ↗
• MalfunctionJul 17, 2025Defective Device; Defective Device

  ON 06/20/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9560-24-2 ARTHREX® UNIVERS REVERS¿ MODULAR GLENOID SYSTEM MODULAR BASEPLATE WAS DEFECTIVE. THIS OCCURRED IN A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED BY OPENING A NEW BASEPLATE AND CENTRAL SCREW (9560-24-2 AND 9561-30S). ADDITIONAL INFORMATION WAS PROVIDED VIA PHONE ON (B)(6) 2025 WHERE THE SALES REPRESENTATIVE STATED WHEN PUTTING THE BASEPLATE TOGETHER WITH THE SCREW AND TRYING TO PUT IT ON THE INSERTER IT WAS NOT CATCHING. I T APPEARED NOT TO BE THREADED AFTER EXAMINING THE DEVICE. THERE WAS A LESS THAN 5-MINUTE DELAY DURING THIS PROCEDURE.

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

  MAUDE report 22529947 ↗
• MalfunctionJul 9, 2025Positioning Failure; Positioning Failure

  ON 6/13/2025, 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 22462344 ↗
• 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 21917626 ↗
• MalfunctionFeb 21, 2025Break; Break

  ON 2/10/2025, 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 21434574 ↗
• MalfunctionOct 7, 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-9560-24-2 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.

  Patient problems: Insufficient Information

  MAUDE report 20385587 ↗
• MalfunctionSep 25, 2024Break; Defective Device; Break; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9561-25S UNIVERS REVERS MODULAR CENTRAL SCREW AND AN AR-9560-24-2 ARTHREX UNIVERS REVERS MODULAS BASEPLATE FAILED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20300753 ↗
• InjuryAug 22, 2024Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED ON 5/14/2025: THE REVISION SURGERY WAS RESCHEDULED PER PATIENT REQUEST TO (B)(6) 2025. IT WAS LATER RESCHEDULED TO (B)(6) 2025 DUE TO SURGEON AVAILABILITY. AND THEN, RESCHEDULED AGAIN PER PATIENT REQUEST TO (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Loss of Range of Motion; Pain

  MAUDE report 20027529 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 1/31/2023 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 19483199 ↗
• MalfunctionApr 29, 2024Use of Device Problem; Use of Device Problem

  ON 10/26/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9561-25S CENTER SCREW AND AR-9560-24-2 MODULES BASEPLATE DID NOT SEAL TOGETHER ON THE BACK TABLE USING THE MORSE TAPER. THE CASE WAS COMPLETED BY OPENED A NEW BASEPLATE AND SCREW.

  Patient problems: Insufficient Information

  MAUDE report 19200673 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9560-24-2 MODULAS BASEPLATE DISASSOCIATED FROM AN AR-9561-25S CENTRAL SCREW DURING INSERTION. THIS WAS DISCOVERED DURING A RTSA PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19152296 ↗
• MalfunctionApr 8, 2024Fitting Problem; Fitting Problem

  ON 04/26/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9560-24-2 MODULAR GLENOID SYSTEM MODULAR BASEPLATE DID NIT FIT CORRECTLY. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO PATIENT HARM REPORTED. REQUESTED ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067913 ↗
• MalfunctionFeb 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  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 18649159 ↗
• MalfunctionFeb 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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: Insufficient Information

  MAUDE report 18634305 ↗
• 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 18032228 ↗
• InjuryMay 1, 2023Defective Device; Defective Device

  ON 4/04/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-08P UNIVERS II HUMERAL STEM 8MM HAD AN INCLINATION SCREW LOCKED IN POSITION WHEN OPENED. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A BIGGER SIZE (9) PRIMARY STEM. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 4/05/2023: THE LOCKED INCLINATION SCREW WAS DISCOVERED DURING IMPLANTATION. THE GLENOID FRACTURE WAS CAUSED BY SCREWING THE GLENOSPHERE TO THE BASE PLATE. ADDITIONAL INFORMATION RECEIVED ON 4/5/2023: THE FAULTY AR-9100-08P ARTHREX UNIVERS II HUMERAL STEM 8MM WAS DISCOVERED PRIOR TO IMPLANTATION. THE SURGEON HAD ORIGINALLY PLANNED FOR AN RSA PROCEDURE BUT DUE TO A FRACTURE OF THE GLENOID WHILE SCREWING IN THE AR-9560-24-2 BASEPLATE AND AN AR-9564-2433-LAT GLENOSPHERE. IT WAS NOT CAUGHT UNTIL THE GLENOSPHERE WAS INSERTED AND THE ENTIRE BASEPLATE ROTATED AND SHIFTED. THE SURGEON PROCEEDED BY REMOVING THE GLENOSPHERE WITH A REMOVAL DEVICE AND THE BASEPLATE WAS PULLED OUT BY HAND. THE CASE WAS COMPLETED USING AN AR-9100-09PC ARTHREX UNIVERS II STEM, SIZE 9. ADDITIONAL INFORMATION RECEIVED ON 4/6/2023; THE PROCEDURE WAS DELAYE

  Patient problems: Bone Fracture(s)

  MAUDE report 16844989 ↗
• InjuryMay 31, 2022Break

  ON 5/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDER WENT A PRIMARY REVERSE PROCEDURE AND FELL 14 MONTHS LATER, POST OPERATIVE. IMMEDIATELY AFTER THE FALL, PATIENT EXPERIENCE SHOULDER PAIN RADIOGRAPHS SHOWED EVIDENCE OF A BROKEN AR-9563-32 PERIPHERAL LOCKING SCREW, A SHIFTER BASEPLATE AND GLENOSPHERE. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022 FOR REMOVAL OF AR-9563-32 PERIPHERAL LOCKING SCREW, WHICH WAS ONLY PARTIALLY REMOVED, SURGEON MADE THE DECISION TO LEAVE A PORTION OF THE BROKEN SCREW, AS ATTEMPTING TO RETRIEVE IT MAY HAVE RESULTED IN ADDITIONAL BONE LOSS. AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9561-25S CENTRAL SCREW, AN AR-9560-24-2 BASEPLATE, AN AR-9564-2436-LAT GLENO SPHERE, AND AN AR-9503S-06 HUMERAL INSERT WERE ALL EXPLANTED DURING REVISION REVERSE TSA PROCEDURE ON (B)(6) 2022. SURGEON COMPLETED CASE IMPLANTING NEW GLENOID IMPLANTS.

  Patient problems: Fall; Foreign Body In Patient; Pain

  MAUDE report 14547425 ↗
• MalfunctionJul 20, 2021Break

  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 12198344 ↗
• 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. SEE ATTACHED PRE-OPERATIVE X-RAYS IMAGES. 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), AR-9503S-03C (LOT: 19.00504).

  Patient problems: Insufficient Information

  MAUDE report 11872355 ↗
• InjuryMay 10, 2021Break; Fracture; Malposition of Device

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A UNIVERS REVERS APEX AND MODULAR GLENOID SYSTEM (MGS) CONSTRUCT DURING A PRIMARY RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY CASE. THE PATIENT INCREASED ACTIVITY PER THE STANDARD PROTOCOL. AT 19 MONTHS POST-OP, THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. AT THE TIME OF REVISION FOR THE PERIPROSTHETIC FRACTURE, THE PATIENT HAD A STABLE MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE REVERS APEX HUMERAL IMPLANTS WERE REMOVED. THE WRIGHT MEDICAL REVIVE REVISION HUMERAL STEM WAS IMPLANTED DUE TO THE PERIPROSTHETIC FRACTURE. AT 26 MONTHS POST-OP FROM THE INITIAL INDEX REVERSE TOTAL SHOULDER PROCEDURE, THE PATIENT PRESENTED WITH NO FUNCTION. X-RAYS SHOWED A FAILED MODULAR GLENOID SYSTEM IMPLANT CONSTRUCT. THE INFERIOR SCREW WAS BROKEN AND THE IMPLANTS HAD SHIFTED. ON (B)(6) 2021, A SECOND REVISION WAS PERFORMED TO REMOVE THE MODULAR GLENOID SYSTEM IMPLANTS. THE GLENOID IMPLANTS WERE REMOVED IN ONE PIECE WITH NO BONE ON GROWTH. A WRIGHT MEDICAL REVERSE GLENOID CONSTRUCT WAS IMPLANTED IN PLACE. NO INFECTION. ADDITIONAL INFORMATION RECEIVED ON 4/27/2021: THE REP REPORTED THE PRIMARY REVERS TOTAL SHOULDER SURGERY WAS DONE ON (B)(6) 2019. THE RE

  Patient problems: Fall

  MAUDE report 11798492 ↗
• InjuryNov 18, 2020Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD UNDERGONE A SHOULDER PROCEDURE (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED AT THE TIME OF ORIGINAL SURGERY: PART NUMBER, LOT NUMBER: AR-9560-24-2, 7266; AR-9561-20P, 7181; AR-9562-20NL, 2018001453; AR-9562-24NL, 2019001012; AR-9563-16, 2019004170; AR-9563-16, 2019003483; AR-9564-2436-LAT, 19.03388. THE PATIENT IS SCHEDULED TO HAVE A SECOND SURGERY (B)(6) 2020. UPDATED INFORMATION PROVIDED 10/30/20: THE PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 4 WEEKS PRIOR TO THE REPORT TO ARTHREX. SERIAL X-RAYS DIAGNOSED GLENOID BASEPLATE LOOSENING. THE REVISION SURGERY TOOK PLACE 10/30/20 AS SCHEDULED. DURING THE REVISION SURGERY ALL ORIGINAL ARTHREX PRODUCTS, LISTED IN THE INITIAL REPORT, WERE EXPLANTED. ONCE THE BASEPLATE WAS REMOVED, ANOTHER MANUFACTURER'S BASEPLATE, PERIPHERAL SCREWS AND GLENOSPHERE WERE IMPLANTED. SEVERAL CULTURE WERE TAKEN AND SENT FOR RAPID TEST TO THE LAB. RAPID TEST RESULTS RETURNED INDICATING LESS THAN 1 NEUTROPHIL. ARTHREX SALES REP WHO WAS PRESENT STATES THE SURGEON DID VOICE CONCERN OF THE LACK OF BONY INGROWTH ON THE BACKSIDE OF THE BASEPLATE. UPDATED INFORMATION PROVIDED 11/2

  Patient problems: Pain

  MAUDE report 10861636 ↗
• InjurySep 16, 2020Mechanics Altered

  IT WAS REPORTED THAT (B)(6) 2019 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD AN AUTOGRAFT TO THE GLENOID ON HER INITIAL SURGERY AND IT DID NOT APPEAR TO HAVE HEALED. THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE REVISION REPORTS THAT THE SURGEON HAD MENTIONED IN SURGERY THAT HE BELIEVED THAT THE LOCKING MECHANISM ON THE BASEPLATE MAY NOT HAVE BEEN FUNCTIONING APPROPRIATELY (THE SCREW WAS NOT LOCKED IN). DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX DEVICES HAD BEEN IMPLANTED: AR-9564-2436-LAT, GLENOSPHERE, LOT 18.00689 , AR-9503S-03, HUMERAL INSERT, LOT 18.00870 , AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 170141708, AR-9561-25P, MODULAR CENTRAL POST, LOT 5368 , AR-9560-24-2, MODULAR BASEPLATE, LOT 5408 AR-9562-36NL, PERIPHERAL SCREW NON-LOCKING, LOT 2018001207, AR-9563-36, PERIPHERAL SCREW LOCKING, LOT 2018001490 , AR-9563-40, PERIPHERAL SCREW LOCKING, LOT 2018001491 , AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, LOT 170125705. DURING THE REVISION SURGERY ALL OFF THE ABOVE LISTED ORIGINAL IMPLANTS WERE EXPLANTED, EXCEPT FOR THE AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, WHICH WAS L

  Patient problems: Impaired Healing

  MAUDE report 10540405 ↗
• InjuryMay 6, 2020Loose 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 (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: Joint Dislocation

  MAUDE report 10028314 ↗