Arthrex® AR-9580-2420-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867341692), received between Jun 2, 2023 and Jan 12, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Use of Device Problem

  ON 22-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-9582-35 MODULAR POST FOR AUGMENTED MGS BASEPLATE 35 MM EXPERIENCED AN ISSUE WITH INSERTING A SCREW INTO THE BASEPLATE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2025. THIS RESULTED IN HAVING TO REMOVE THE AR-9582-35 AND AN AR-9580-2420-2. THE CASE CONTINUED USING ANOTHER AR-9582-35 AND ANOTHER AR-9580-2420-2. THERE WAS NO DELAY IN THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24035629 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/8/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A SUBLUXATION, WHICH RESULTED IN A REVISION OF THE COMPONENTS ON (B)(6) 2023. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/25/2025 VIA CLINDEX NOTIFICATION: ON (B)(6) 2023, THE PATIENT REPORTED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT RETURNED AND REPORTED DIFFICULTY WITH RAISING THE ARM ALONG WITH CONTINUED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2025. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9580-2420-2 UNIVERS REVERS AUGMENTED BASEPLATE, AN AR-9501-10S UNIVERS REVERS APEX HUMERAL STEM, AND AN AR-9503S-03 ARTHREX UNIVERS REVERS HUMERAL INSERT WERE EXPLANTED. THE CASE WAS COMPLETED USING A NEW GLENOSPHERE, A HUMERAL INSERT, A SPACER, AND A BASEPLATE.

  Patient problems: Pain

  MAUDE report 21664180 ↗
• 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 9/13/2022 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 FOR

  Patient problems: Insufficient Information

  MAUDE report 19829622 ↗
• InjuryMay 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 4/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9580-2420-2 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE WAS REVISED DUE TO LOOSENING. A NEW PLATE WAS IMPLANTED. THIS WAS DISCOVERED DURING A REVISION RTSA PROCEDURE ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19358969 ↗
• 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 17054624 ↗