Arthrex® AR-9582-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867341845), received between Oct 11, 2022 and Mar 4, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Patient Device Interaction Problem

  ON 28-JAN-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 09-FEB-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 10-FEB-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 24512800 ↗
• 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 22521354 ↗
• InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 2/10/2025, 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 21700218 ↗
• InjuryJan 15, 2025Patient 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, 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 21160450 ↗
• MalfunctionAug 22, 2024Positioning Failure; Positioning Failure

  ON (B)(6)2024, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A COMPRESSOR MADE AN ABNORMALLY LOUD CREAKING NOISE WHEN THE AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE 25 MM AND AR-9580-2410-2S UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE 24 MM+2 WAS PLACED TOGETHER. THE POST AND BASEPLATE DID NOT DISENGAGE. HOWEVER, A NEW BASEPLATE AND POST WERE USED TO COMPLETE THE CASE AND AVOID COMPLICATIONS. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER REPLACEMENT PROCEDURE ON 7/17/2024. NOTHING BROKE IN THE PATIENT. THE CASE WAS ONLY DELAYED FOR ABOUT FIVE MINUTES WITH ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20030824 ↗
• InjuryAug 5, 2024Patient Device Interaction Problem; 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 19907231 ↗
• MalfunctionMay 8, 2024Connection Problem; Connection Problem

  ON 10/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-9580-2410 AUGMENTED BASE PLATE, AND A AR-9582-25 MODULAR POST FOR AUGMENTED MGS BASEPLATE ARE NOT LOCKING. THIS OCCURRED ON 10/25/2022 DURING A REVERS TOTAL SHOULDER ARTHROPLASTY WHEN THE 2 DEVICES WOULD NOT CONNECT TOGETHER. ANOTHER DEVICE OF EACH WERE OPENED, AND WORKED ACCORDINGLY. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267445 ↗
• MalfunctionApr 9, 2024Defective Device; Defective Device

  ON 9/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9580-2420 24MM BASEPLATE AND AN AR-9582-25 MODULAR POST HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2022. THE BASEPLATE WAS PREPARED WITH THE MODULAR POST ON THE BACK TABLE, WITH THE DESIRED LENGTH, AND THEN PUT INTO THE PATIENT. IT WAS NOTICED THAT DURING THE SCREW INSERTION, THE BASEPLATE ROTATED SLIGHTLY AND WAS LOOSE INSIDE THE PATIENT. THE SCREWS WERE TAKEN OUT AND THE BASEPLATE WITH THE MODULAR POST WAS TAKEN OUT OF THE PATIENT. A DIFFERENT IMPLANT WAS USED, PART AND LOT NUMBER UNKNOWN, AND A LONGER POST, PART, AND LOT NUMBER UNKNOWN, WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY NO IMPACT TO THE PATIENT. NOTHING BROKE INSIDE THE PATIENT. THE COMPLAINT DEVICES WERE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071273 ↗
• InjuryFeb 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 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 1/11/2024, 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 18696474 ↗
• 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 PERIPH

  Patient problems: Failure of Implant

  MAUDE report 17054629 ↗
• MalfunctionOct 11, 2022Material Separation; Positioning Problem

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9580-2410 MGS BASEPLATE AND AR-9582-25 MODULAR POST WOULD NOT SEAT AND WERE UNABLE TO BE RE-COMPRESSED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: "AFTER COMPRESSING THE MGS AUGMENTED BASEPLATE AND THE MODULAR POST TOGETHER, THE IMPLANT WAS INSERTED INTO THE GLENOID. IT WAS NOT SEATING, AND WHEN REMOVED, THE TWO PIECES CAME APART. WE WERE THEN UNABLE TO RE-COMPRESS THEM AND FORCED TO OPEN NEW IMPLANTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574986 ↗