Arthrex® AR-9563-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888867296800), received between Feb 3, 2020 and Mar 4, 2026 — classified as 22 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (10 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Break

  ON (B)(6) 2026, THE PATIENT REPORTED VIA EMAIL THAT, FOLLOWING A REVERSE TOTAL SHOULDER SURGERY, THEY EXPERIENCED INCREASING POSTOPERATIVE PAIN. X-RAYS REPORTEDLY SHOWED A BROKEN SCREW, AND A CT SCAN DEMONSTRATED A LOOSE IMPLANT. THE PATIENT IS NOW SCHEDULED FOR A CORRECTIVE SURGICAL PROCEDURE. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON (B)(6) 2026: THE PATIENT IS SCHEDULED TO UNDERGO A REVISION LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2026. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. OVER TIME, THE PATIENT DEVELOPED SIGNIFICANT LEFT SHOULDER PAIN. THE PATIENT¿S SPOUSE REPORTED PROGRESSIVE DISCOMFORT IN THE PATIENT¿S LEFT ARM. DIAGNOSTIC IMAGING WAS PERFORMED, INCLUDING AN X-RAY ON (B)(6) 2025, WHICH IDENTIFIED A FRACTURED SCREW, FOLLOWED BY A CT SCAN ON (B)(6) 2025 THAT DEMONSTRATED LOOSENING OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE FROM THE PATIENT'S RELATIVE ON (B)(6) 2026: THE PATIENT'S SPOUSE REPORTED THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, ALL COMPONENTS OF THE LEFT SHOULDER WERE R

  Patient problems: Discomfort; Pain

  MAUDE report 24512691 ↗
• MalfunctionJan 12, 2026Positioning Failure

  ON 19-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9563-16 PERIPHERAL LOCKING SCREW DID NOT LOCK INTO AN AR-9580-2410S 24MM BASE PLATE DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025. THE ISSUE WAS RESOLVED BY USING TWO REPLACEMENT AR-9563-20 PERIPHERAL LOCKING SCREWS (5.5 X 20 MM) TO COMPLETE THE CASE. THERE WAS NO DELAY, NO ADDITIONAL ANESTHESIA, AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035625 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 05/28/2025, 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 GLENOSPH

  Patient problems: Unspecified Infection

  MAUDE report 22521377 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 05/28/2025, 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 GLENOSPH

  Patient problems: Unspecified Infection

  MAUDE report 22521369 ↗
• 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 21774121 ↗
• InjuryMar 26, 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 A LOOSENING OF THE GLENOID SIDE IMPLANTS. AN X-RAY ON (B)(6)2024, SHOWED LOSS OF FIXATION OF THE BASEPLATE. THE PATIENT WAS REVISED ON (B)(6)2024. THE EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS IMPLANTED ON (B)(6)2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 3/7/2025: AR-9580-2410 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, THREE AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING, AN AR-9564-2433-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AND AN AR-9503XS-03 UNIVERS REVERS MODULAR GLENOID SYSTEM, HUMERAL INSERT WERE EXPLANTED DURING THE REVISION SURGERY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21700214 ↗
• MalfunctionMar 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 (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 GLENOS

  Patient problems: Insufficient Information

  MAUDE report 21559765 ↗
• 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 21160453 ↗
• InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9564-2442-LAT GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR A REVERSE SHOULDER ARTHROPLASTY. POSTOPERATIVELY THE PATIENT EXPERIENCED PAIN AND A CT SCAN REVEALED GLENOSPHERE AND GLENOSPHERE SET SCREW DISENGAGED FROM THE BASEPLATE. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH A NEW GLENOSPHERE ALONG WITH HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: DURING THE REVISION SURGERY, THE AR-9502F-39LCPC SUTURECUP, THE AR-9503-3942-3 HUMERAL INSERT, THE AR-9501-07P HUMERAL STEM, THE AR-9582-20 MODULAR POST, THE AR-9563-28 PERIPHERAL LOCKING SCREW, THE AR-9563-16 PERIPHERAL LOCKING SCREW, THE AR-9563-20 PERIPHERAL LOCKING SCREW, THE AR-9562-40NL PERIPHERAL LOCKING SCREW, THE AR-9580-2010-2S BASEPLATE, AND AR-9564-2442-LAT GLENOSPHERE WAS REMOVED. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON AND AT THE SAME FACILITY.

  Patient problems: Pain

  MAUDE report 20726076 ↗
• 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 20025809 ↗
• InjuryAug 20, 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 20005937 ↗
• MalfunctionAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 7/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS DEVICES IMPLANTED ON (B)(6) 2024. ON (B)(6) S2024, THE PATIENT STARTED TO EXPERIENCE PAIN. IT WAS SUSPECTED THE PATIENT SUFFERED AN ACROMIAL FRACTURE, WHICH WAS CONFIRMED IN APRIL VIA CT SCAN. THE PATIENT WAS IMMOBILIZED IN A SLING FOR SIX WEEKS. ON (B)(6) 2024, THE PATIENT REPORTED NO PAIN; X-RAY IMAGES REVEALED A HEALED FRACTURE. THE PATIENT DID NOT SUFFER A FALL OR HAVE AN INJURY. THE PAIN BEGAN AFTER PHYSICAL THERAPY. THE IMPLANTS ARE NOT LOOSE OR BROKEN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19940761 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 7/18/2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED BONE FRACTURES IN THE TARGET SHOULDER. THIS EVENT WAS INDICATED AS POSSIBLY RELATED TO THE UNIVERS REVERS DEVICES IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT STARTED TO EXPERIENCE PAIN. IT WAS SUSPECTED THE PATIENT SUFFERED AN ACROMIAL FRACTURE, WHICH WAS CONFIRMED IN APRIL VIA CT SCAN. THE PATIENT WAS IMMOBILIZED IN A SLING FOR SIX WEEKS. ON 7/16/2024, THE PATIENT REPORTED NO PAIN; X-RAY IMAGES REVEALED A HEALED FRACTURE. THE PATIENT DID NOT SUFFER A FALL OR HAVE AN INJURY. THE PAIN BEGAN AFTER PHYSICAL THERAPY. THE IMPLANTS ARE NOT LOOSE OR BROKEN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19940672 ↗
• InjuryAug 5, 2024Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 11/4/2024: ON (B)(6) 2024, THE PATIENT'S IMPLANTS WERE CONVERTED FROM FAILED REVERS TO A HEMIARTHROPLASTY DUE TO THE DISPLACED GLENOID COMPONENTS FROM THE BROKEN SCREWS. AT THIS TIME, IT IS UNKNOWN WHICH ARTHREX PRODUCTS FROM THE ORIGINAL SURGERY ON (B)(6) 2023 WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Pain

  MAUDE report 19907279 ↗
• 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 18695143 ↗
• 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) 2023. 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 17364001 ↗
• 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) OF 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 (B)(6)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 PERIPHER

  Patient problems: Failure of Implant

  MAUDE report 17054687 ↗
• InjuryApr 18, 2023Unexpected Therapeutic Results; Patient Device Interaction Problem; Unexpected Therapeutic Results; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A REVISION SHOULDER ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6) 2023 DUE TO AN INFECTION. THE SURGEON REMOVED AN AR-9580-2420 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE, AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE, AN AR-9562-32NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 32 MM, AN AR-9562-24NL UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, NON-LOCKING 4.5 X 24 MM, AN AR-9563-20 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 20 MM, AN AR-9563-16 UNIVERS REVERS MODULAR GLENOID SYSTEM, PERIPHERAL SCREW, LOCKING 5.5 X 16 MM, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS MODULAR GLENOID SYSTEM GLENOSPHERE, AN AR-9503S-06 ARTHREX UNIVERS REVERS HUMERAL INSERT, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9501-05P UNIVERS REVERS HUMERAL STEM. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2021. ABOUT TEN MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE SYMPTOMS OF INFECTION. A CULTURE WAS TAKEN OFF THE INFECTED AREAS, BUT RESULTS ARE STILL PENDING. THE SAME SURGEON AT

  Patient problems: Unspecified Infection

  MAUDE report 16762291 ↗
• InjuryJun 2, 2022Break; Unstable; Naturally Worn

  ON 5/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A RIGHT SHOULDER RTSA ON (B)(6) 2019. 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. ADDITIONAL INFORMATION RECEIVED ON 5/12/2022: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2019 AND PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ON (B)(6) 2019, AN AR-9501-05P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503-3633-3 HUMERAL INSERTER, (2) AR-9560-24 BASEPLATE, FROM DIFFERENT LOT NUMBERS, AN AR-9561-20S CENTRAL SCREW, AN AR-9561-25S CENTRAL SCREW, (3) AR-9563-16 PERIPHERAL LOCKING SCREWS, ONE BEING FROM A DIFFERENT LOT NUMBER, AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2020. HOWEVER, DURING REVISION SURGERY ON (B)(6) 2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCREW, AR-9

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

  MAUDE report 14573600 ↗
• InjuryJun 2, 2022Unstable; Naturally Worn

  ON 5/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT HAD A RIGHT SHOULDER RTSA ON (B)(6) 2019. 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. ADDITIONAL INFORMATION RECEIVED ON 5/12/2022: THE ORIGINAL PROCEDURE OCCURRED ON 5/24/52019 AND PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. BOTH PROCEDURES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON. ON (B)(6) 2019, AN AR-9501-05P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503-3633-3 HUMERAL INSERTER, (2) AR-9560-24 BASEPLATE, FROM DIFFERENT LOT NUMBERS, AN AR-9561-20S CENTRAL SCREW, AN AR-9561-25S CENTRAL SCREW, (3) AR-9563-16 PERIPHERAL LOCKING SCREWS, ONE BEING FROM A DIFFERENT LOT NUMBER, AND AND AR-9564-2433 GLENOSPHERE WERE IMPLANTED. SALES REPRESENTATIVE CANNOT CONFIRM WHICH DEVICES WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2020. HOWEVER, DURING REVISION SURGERY ON (B)(6) 2020, AN AR-9503-3633-3C HUMERAL INSERTER, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, AND AR-9563-16 PERIPHERAL LOCKING SCREW, A

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

  MAUDE report 14573590 ↗
• InjuryMay 23, 2022Unstable; Naturally Worn

  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 14469384 ↗
• 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 AR-9560-24-2 LOT NUMBER 7266. PART NUMBER AR-9561-20P LOT NUMBER 7181. PART NUMBER AR-9562-20NL LOT NUMBER 2018001453. PART NUMBER AR-9562-24NL LOT NUMBER 2019001012. PART NUMBER AR-9563-16 LOT NUMBER 2019004170. PART NUMBER AR-9563-16 LOT NUMBER 2019003483. PART NUMBER AR-9564-2436-LAT LOT NUMBER 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 (B)(6) 2020 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 S

  Patient problems: Pain

  MAUDE report 10861824 ↗
• 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 (B)(6) 2020: 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 (B)(6) 2020 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 PROVIDE

  Patient problems: Pain

  MAUDE report 10861785 ↗
• InjuryMay 20, 2020Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL REVERSE SHOULDER PROCEDURE WITH MODIFIED GLENOID SYSTEM IN (B)(6) 2019. THE PATIENT HAD RECENTLY UNDERGONE A REVISION PROCEDURE ON (B)(6) 2020 DUE TO PAIN AND CONSTRUCT DISLOCATION. AT THE (B)(6) REVISION, THE HUMERAL INSERT WAS EXPLANTED AND A SPACER AND NEW INSERT WERE IMPLANTED. THE (B)(6) 2020 REVISION WAS REPORTED UNDER CASE (B)(4). ON (B)(6) 2020, THE PATIENT HAD A THIRD PROCEDURE DUE TO NEUROPATHY; THE FOLLOWING DEVICES WERE ALL EXPLANTED: IMPLANTS: AR-9503S-03C (LOT 19.00210), AR-9555-06 (LOT 16.01037), AR-9564-2436-LAT (LOT 19.00689) AND AR-9560-24 (LOT 02191932) AND 4 SCREWS: AR-9563-16, AR-9563-28 (QTY2) AND AR-9563-20 TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING DEVICES: AR-9502-36ARCA (LOT 18.00755) AND AR-9550-19RCA (LOT 10071328).

  Patient problems: Neuropathy; Pain

  MAUDE report 10074356 ↗
• InjuryFeb 3, 2020Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER TOOK PLACE ON (B)(6) 2020. THE REP REPORTED THE REVISION PROCEDURE WAS DUE TO A HIGH SUSPICION OF AN INFECTION, AND THE BASEPLATE LOOSENING. PRIOR TO THE REVISION PROCEDURE THE PATIENT WAS EXPERIENCING PAIN AND SWELLING AROUND THE SURGICAL SITE. X-RAYS WERE TAKEN DURING A FOLLOW-UP VISIT AND REVEALED THE LOOSENED BASEPLATE. CULTURES WERE TAKEN DURING THE REVISION PROCEDURE AND SENT FOR TESTING. AT THIS TIME AN INFECTION HAS NOT BEEN CONFIRMED. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE REP REPORTED AT THIS TIME THE DATE OF THE PRIMARY SURGERY, AND FULL LIST OF ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY PROCEDURE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION PROCEDURE; AR-9503-3633-3 / LOT: 18.00158 / QTY.: 1, AR-9501-05P / LOT: UNKNOWN / QTY.: 1, AR-9555-06 / LOT: 18.01505 / QTY.: 1, AR-9502F-36CPC / LOT: 18.00745 / QTY.: 1, AR-9564-2433-LAT / LOT: 17.04762 / QTY.: 1, AR-9563-16 / LOT: 18.00182 / QTY.: 1. AN ARTHREX BASEPLATE AND SCREW WERE ALSO REMOVED. HOWEVER, THE PART AND LO

  Patient problems: Pain; Swelling

  MAUDE report 9659101 ↗