Arthrex® AR-9563-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888867296848), received between Oct 30, 2020 and Aug 13, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Break; Break

  ON 07/25/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE AR-9580-2420-2S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE (24 MM) HAD FAILED, NECESSITATING A REVISION PROCEDURE. THE ISSUE ORIGINATED DURING A REVERSE SHOULDER ARTHROPLASTY PERFORMED ON (B)(6) 2025. TO ADDRESS THE FAILURE, THE SURGICAL TEAM SUCCESSFULLY REMOVED THE AR-9580-2420-2S BASEPLATE (24 MM), AR-9582-30 MODULAR POST FOR AUGMENTED MGS BASEPLATE 30 MM, AR-9563-24 PERIPHERAL LOCKING SCREW, AND AR-9563-36 PERIPHERAL LOCKING SCREW. THEY PROCEEDED WITH THE IMPLANTATION OF A NON-ARTHREX SMALL SCREW BASEPLATE, WHICH WAS SUPPLEMENTED BY BONE GRAFTING. A NEW ARTHREX CUP AND POLYETHYLENE LINER WERE ALSO PLACED. THE REVISION SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/31/2025.

  Patient problems: Failure of Implant

  MAUDE report 22792984 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY HAD EXPERIENCED A DEEP INFECTION. ON (B)(6) 2025, THE PATIENT PRESENTED WITH INCREASED SWELLING AND ACHING IN THE OPERATIVE SHOULDER, WITH SYMPTOMS REPORTED TO HAVE BEGUN ABOUT THREE TO FOUR WEEKS PRIOR TO THE CLINIC VISIT ON (B)(6) 2025. THE PATIENT WAS REFERRED FOR SYNOVASURE TESTING ON (B)(6) 2025, AND A VISIT ON (B)(6) 2025 CONFIRMED THE INFECTION. A REVISION WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 6/20/2025: DURING THE REVISION SURGERY ON (B)(6) 2025, AN AR-9501-11S UNIVERS REVERS APEX HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9503-3639-3 UNIVERS REVERS MODULAR GLENOID SYSTEM COMBO HUMERAL INSERT, TWO AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9563-32 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL LOCKING SCREW, AN AR-9564-2439-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSP

  Patient problems: Unspecified Infection

  MAUDE report 22521375 ↗
• InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 3/4/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED LOOSENING OF HUMERAL SIDE IMPLANTS. THE PATIENT SUFFERED AN INJURY AFTER LIFTING A FIVE-POUND BOX. THE X-RAYS INDICATED A SMALL NON-DISPLACED FRACTURE AND LOOSE HUMERAL COMPONENTS. THE PATIENT UNDERWENT A REVISION RSA AND OFIF PROCEDURE ON (B)(6) 2022. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERSE REVERSE SYSTEM IMPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/19/2025: DURING THE REVISION SURGERY ON (B)(6) 2022 AN AR-9564-2842-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, TWO AR-9563-24 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9562-32NL UNIVERS REVERS PERIPHERAL SCREW, AN AR-9502F-42RCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9501-11P ARTHREX UNIVERS REVERS HUMERAL STEM, AN AR-9550-15 ARTHREX UNIVERS REVERS SPACER, AND AN AR-9503L-06C ARTHREX UNIVERS REVERS HUMERAL INSERT WAS REMOVED. THE CASE WAS COMPLETED WITH NEW ARTHREX UNIVERS REVERS IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 21774139 ↗
• InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED LOOSENING OF HUMERAL SIDE IMPLANTS. THE PATIENT SUFFERED AN INJURY AFTER LIFTING A FIVE-POUND BOX. THE X-RAYS INDICATED A SMALL NON-DISPLACED FRACTURE AND LOOSE HUMERAL COMPONENTS. THE PATIENT UNDERWENT A REVISION RSA AND OFIF PROCEDURE ON (B)(6) 2022. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERSE REVERSE SYSTEM IMPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 3/19/2025: DURING THE REVISION SURGERY ON (B)(6) 2022 AN AR-9564-2842-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, TWO AR-9563-24 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9562-32NL UNIVERS REVERS PERIPHERAL SCREW, AN AR-9502F-42RCPC ARTHREX UNIVERS REVERS SUTURE CUP, AN AR-9501-11P ARTHREX UNIVERS REVERS HUMERAL STEM, AN AR-9550-15 ARTHREX UNIVERS REVERS SPACER, AND AN AR-9503L-06C ARTHREX UNIVERS REVERS HUMERAL INSERT WAS REMOVED. THE CASE WAS COMPLETED WITH NEW ARTHREX UNIVERS REVERS IMPLANTS.

  Patient problems: Bone Fracture(s)

  MAUDE report 21774126 ↗
• InjuryMar 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 2/11/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A BONE FRACTURE IN THE TARGETED SHOULDER. ABOUT SEVEN MONTHS POST OPERATION, THE PATIENT MADE A QUICK TURN AROUND AND ENDED UP FRACTURING THE GLENOID CAVITY OF RIGHT SCAPULA. THIS WAS CONFIRMED VIA A CT SCAN ON (B)(6) 2024. THE PATIENTS PAIN BEGAN TO IMPROVE AS OF ON (B)(6) 2024. THE PATIENT REPORTED DECREASED RANGE OF MOTION ON (B)(6) 2024 AND SHARP PAIN ON (B)(6) 2025. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS SYSTEM IMPLANTED ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 2/21/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD, AN AR-9501-04-135R UNIVERS REVERS STEM, AN AR-9503-3336-3 UNIVERS REVERS MODULAR GLENOID SYSTEM HUMERAL INSERT, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9563-28 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2436 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLE

  Patient problems: Insufficient Information

  MAUDE report 21559762 ↗
• InjuryJan 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, FIVE MONTHS POSTOPERATIVE, PRESENTED WITH FULLNESS IN THE ANTERIOR OF THE DELTOPECTORAL INCISION, WHICH HAS TO BE FLUCTUANCE. THE INCISION WAS DRAINED, AND A CULTURE WAS SENT TO THE LAB, WHICH INDICATED AN INFECTION. THE PHYSICIAN DECIDED TO PLACE A PICC LINE FOR IV ANTIBIOTICS. THE PATIENT ALSO UNDERWENT AN EXPLANT PROCEDURE AND HAD AN ANTIBIOTIC CEMENT SPACER IMPLANTED ON (B)(6) 2024. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2024. THIS EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX IMPLANT SYSTEM. ADDITIONAL INFORMATION RECEIVED ON 1/3/2024: DURING THE REVISION SURGERY, AN AR-9503-3639-3 HUMERAL INSERT, AN AR-9563-16 PERIPHERAL SCREW, AN AR-9563-24 PERIPHERAL SCREW, AN AR-9563-32 PERIPHERAL SCREW, AN AR-9563-44 PERIPHERAL SCREW, AN AR-9564-2439-LAT GLENOSPHERE, AN AR-9580-2420-2S BASEPLATE, AND AR-9582-25 MODULAR POST WERE EXPLANTED. THE REVISION SURGERY WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21160454 ↗
• InjuryAug 21, 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 20014131 ↗
• InjuryJul 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 7/9/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS. IMAGES WERE TAKEN ON 6/19/2024, SHOWING THE PATIENT NO LONGER HAD THE ORIGINAL ARTHREX IMPLANTS FROM THE ORIGINAL SURGERY ON (B)(6) 2022. UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED ON (B)(6) 2022 AT AN OUTSIDE FACILITY. AN AR-9501-09S UNIVERS REVERS APEX HUMERAL STEM SIZE 9, AN AR-9502F-36RCPC ARTHREX UNIVERS REVERS SUTURE CUP 36 MM, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE 20 MM, AN AR-9580-2420-2 UNIVERS REVERS MODULAR GLENOID SYSTEM, AUGMENTED BASEPLATE 24 MM +2, 20 DEGREE FULL, TWO AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9503-3633-3C UNIVERS REVERS MODULAR GLENOID SYSTEM CONSTRAINED COMBO HUMERAL INSERT 36 +3C / 33, AN AR-9564-2433 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE 33/24, AND TWO AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 24 MM, WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION OTHER THAN THE DATE OF SURGERY WAS AVAILABLE F

  Patient problems: Insufficient Information

  MAUDE report 19829655 ↗
• InjuryJul 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS. IMAGES WERE TAKEN ON (B)(6) 2024, SHOWING THE PATIENT NO LONGER HAD THE ORIGINAL ARTHREX IMPLANTS FROM THE ORIGINAL SURGERY ON (B)(6) 2022. UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THE PATIENT WAS REVISED ON (B)(6) 2022 AT AN OUTSIDE FACILITY. AN AR-9501-09S UNIVERS REVERS APEX HUMERAL STEM SIZE 9, AN AR-9502F-36RCPC ARTHREX UNIVERS REVERS SUTURE CUP 36 MM, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE 20 MM, AN AR-9580-2420-2 UNIVERS REVERS MODULAR GLENOID SYSTEM, AUGMENTED BASEPLATE 24 MM +2, 20 DEGREE FULL, TWO AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9503-3633-3C UNIVERS REVERS MODULAR GLENOID SYSTEM CONSTRAINED COMBO HUMERAL INSERT 36 +3C / 33, AN AR-9564-2433 ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE 33/24, AND TWO AR-9563-24 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 24 MM, WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2022. NO OTHER INFORMATION OTHER THAN THE DATE OF SURGERY WAS AVAILA

  Patient problems: Insufficient Information

  MAUDE report 19829652 ↗
• InjuryFeb 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9660-R CENTRAL POST EXTRACTOR GOT STUCK IN THE IMPLANT DURING IMPLANT REMOVAL. THIS WAS DISCOVERED DURING A REVISION REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/31/2024: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2021. DUE TO PAIN, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9503S-03 HUMERAL INSERT, AN AR-9555-09 UNIVERS REVERS SPACER, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AN AR-9563-24 PERIPHERAL LOCKING SCREW, AN AR-9563-28 PERIPHERAL LOCKING SCREW, AN AR-9564-2436 GLENOSPHERE, AN AR-9580-2410-2 BASEPLATE, AND AN AR-9582-25 MODULAR POST WERE EXPLANTED. ONLY AN AR-9501-10S UNIVERS REVERS APEX STEM AND AN AR-9502F36RCPC SUTURE CUP REMAINED FROM THE ORIGINAL SURGERY. TO COMPLETE THE REVISION SURGERY, AN AR-9503S-03C HUMERAL INSERT, AN AR-9555-12 UNIVERS REVERS SPACER, AN AR-9560-24-4 BASEPLATE, AN AR-9561-30S CENTRAL SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, (2) AR-9563-28 PERIPHERAL LOCKING SCREW,

  Patient problems: Implant Pain

  MAUDE report 18695243 ↗
• InjuryFeb 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 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 A

  Patient problems: Unspecified Infection

  MAUDE report 18622819 ↗
• InjuryJul 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION AND LOOSENED BASEPLATE. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AFTER THE ORIGINAL PROCEDURE ON (B)(6) 20203. DURING THE POST-OPERATIVE VISIT, RADIOGRAPHS INDICATED A LOOSENED BASEPLATE, BUT THE INFECTION TYPE WAS NOT YET CONFIRMED. DURING THE REVISION SURGERY, AN AR-9564-2433-LAT GLENOSPHERE, AN AR-9580-2420 BASEPLATE, AN AR-9582-20 MODULAR POST, AN AR-9501-10S HUMERAL STEM, AN AR-9502F-33CPC SUTURE CUP, AN AR-9503XS-03 HUMERAL INSERT, AN AR-9504-06 HUMERAL SPACER, AN AR-9562-24NL PERIPHERAL NON-LOCKING SCREW, AN AR-9563-16 PERIPHERAL LOCKING SCREW, AN AR-9563-20 PERIPHERAL LOCKING SCREW, AND AR-9563-24 PERIPHERAL LOCKING SCREW WERE EXPLANTED. THE CASE WAS COMPLETED BY TAKING CULTURES FOR FURTHER TESTING AND PLACING ANTIBIOTIC SPACERS. NO ADDITIONAL ARTHREX PRODUCTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17364024 ↗
• InjuryJun 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9580-2420-2 BASEPLATE WAS LOOSENED POST-OPERATIVE. IN (B)(6) 2023, THE PATIENT REPORTED AN ONGOING PAINFUL SHOULDER, AND RADIOGRAPHS REVEALED THE LOOSENED BASEPLATE WITH A POST-MIGRATING SUPERIOR POSTERIOR OF THE GLENOID. A REVISION SURGERY TOOK PLACE ON 5/9/2023 TO REMOVE THE DEVICES IMPLANTED DURING THE ORIGINAL PROCEDURE ON (B)(6) 2021. DURING THE REVISION OF SHOULDER ARTHROPLASTY, AN AR-9580-2420-2 BASEPLATE, AN AR-9582-25 MODULAR POST, AN AR-9563-16 AR-9563-16, AN AR-9563-24 PERIPHERAL SCREW, AN AR-9562-28NL PERIPHERAL SCREW, AN AR-9562-24NL PERIPHERAL SCREW, AND AN AR-9564-2439-LAT GLENOSPHERE WERE SUCCESSFULLY REMOVED. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ADDITIONAL INFORMATION RECEIVED ON 5/11/2023: THE REVISION SURGERY WAS COMPLETED BY IMPLANTING AN AR-9503M-03 HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP , AN AR-9505-09 UNIVERS REVERS SPACER 39+9MM, AN AR-9563-32 5.5X32MM PERIPHERAL SCREW, LOCKING, AN AR-9564-2839 39/28 GLENOSPHERE, AN AR-9560-28 28MM BASEPLATE, MODULAR, AN AR-9562-24NL 4.5X24MM PERIPHERAL SCREW, NON-LOCKING, AND AR-9563-20 5.5X20MM PERIPHERAL S

  Patient problems: Failure of Implant

  MAUDE report 17054701 ↗
• InjuryMay 23, 2022Naturally Worn; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A LEFT SHOULDER RTSA ON (B)(6) 2020. ON (B)(6) 2022, 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. DURING THE REVISION SURGERY ON (B)(6) 2022, AN AR-9560-24 UNIVERS REVERS BASEPLATE, AR-9561-25S UNIVERS REVERS CENTRAL SCREW, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS PERIPHERAL LOCKING SCREW, AN AR-9564-2433-LAT UNIVERS REVERS GLENOSPHERE, AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, AND AN AR-9503-3633-3C UNIVERS REVERS CONSTRAINED COMBO HUMERAL INSERT WERE REMOVED. SURGEON DID NOT REMOVE THE UNIVERS REVERS STEM THAT WAS IMPLANTED DURING ORIGINAL PROCEDURE ON (B)(6) 2022. TO COMPLETE THE REVISION SURGERY, AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD WERE IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14469365 ↗
• MalfunctionMay 23, 2022Unstable; Naturally Worn

  ON 5/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A LEFT SHOULDER RTSA ON (B)(6) 2020. ON (B)(6) 2022, 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. DURING THE REVISION SURGERY ON (B)(6) 2022, AN AR-9560-24 UNIVERS REVERS BASEPLATE, AR-9561-25S UNIVERS REVERS CENTRAL SCREW, AN AR-9563-16 UNIVERS REVERS PERIPHERAL SCREW, AN AR-9563-24 UNIVERS REVERS PERIPHERAL LOCKING SCREW, AN AR-9564-2433-LAT UNIVERS REVERS GLENOSPHERE, AN AR-9502F-36CPC UNIVERS REVERS SUTURE CUP, AND AN AR-9503-3633-3C UNIVERS REVERS CONSTRAINED COMBO HUMERAL INSERT WERE REMOVED. SURGEON DID NOT REMOVE THE UNIVERS REVERS STEM THAT WAS IMPLANTED DURING ORIGINAL PROCEDURE ON (B)(6) 2022. TO COMPLETE THE REVISION SURGERY, AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER AND AN AR-9550-19RCA UNIVERS REVERS CA HUMERAL HEAD WERE IMPLANTED SUCCESSFULLY.

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

  MAUDE report 14468946 ↗
• 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 11872378 ↗
• 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 11798414 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT MAY HAVE HAD AN ISSUE AS A RESULT OF SURGERY INVOLVING ARTHREX IMPLANTS. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD A 10/1/2019 REVERSE SHOULDER REPLACEMENT PROCEDURE. AFTER THE NERVE BLOCK HAD WORN OFF, APPROXIMATELY 24 HOURS POST SURGERY THE PATIENT WAS EXPERIENCING NUMBNESS IN THE SURGICAL ARM'S PALM, HALF OF RING FINGER AND THE PINKIE FINGER. THE PATIENT WAS DIAGNOSED WITH ULNAR NERVE PALSY AND TOLD IT MAY TAKE A YEAR TO RESOLVE. PATIENT CONSULTED WITH A NEUROLOGIST, WHO SAID NOTHING COULD BE DONE. THE ULNAR NERVE WAS DAMAGED. NO SECOND SURGERY HAS BEEN PERFORMED. THE FOLLOWING ARE THE ARTHREX PRODUCTS THAT WERE IMPLANTED ON (B)(6) 2019: AR-9560 28-4 / LOT: 6094; AR-9561-25P / LOT: 5685; AR-9502F-39RCPC / LOT: 19.00275; AR-9501-105 / LOT: 18.0037; AR-9564-2839-LAT / LOT: 18.02027; AR-9562-28NL / LOT: 2018005880; AR-9503M-06 / 19.00667; AR-9563-28 / LOT: 2019001687; AR-9563-24 / LOT: 19.02242; AR-9562-28NL / LOT: 2018005880.

  Patient problems: Nerve Damage; Numbness

  MAUDE report 10763793 ↗