Arthrex® AR-9582-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867341852), received between Apr 11, 2024 and Apr 16, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INVERSE SHOULDER PROSTHESIS SURGERY ON (B)(6) 2026 THE PATIENT HAS DEVELOPED AN INFECTION. ON (B)(6) 2026 ALL IMPLANTS WERE REMOVED AND THE AFFECTED AREAS WERE CLEANSED AND TREATED. A NEW PROSTHESIS WILL BE IMPLANTED IN 6-8 WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 24895145 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/19/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING THE INSERTION OF AN AR-9582-30 MODULAR POST AND AN AR-9580-2420-2S BASEPLATE, THE TWO COMPONENTS DID NOT ENGAGE PROPERLY, RESULTING IN SEPARATION. A SECOND SET OF COMPONENTS, ANOTHER POST AND BASEPLATE, WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: DURING THE PROCEDURE, THE AR-9582-30 MODULAR POST AND THE AR-9580-2420-2S BASEPLATE DISENGAGED INSIDE THE PATIENT AFTER BEING ASSEMBLED ON THE BACK TABLE. NO COMPONENTS BROKE, AND ALL PIECES WERE RETRIEVED. NO OTHER ARTHREX PRODUCTS WERE AFFECTED. THE CASE WAS COMPLETED USING AR-9580-2420-2S MODULAR GLENOID SYSTEM AUGMENTED BASE PLATE 24 MM+2 (LOT 1306512225) AND AR-9582-30 MODULAR POST FOR AUGMENTED MGS BASEPLATE 30 MM (LOT 1749132422). SURGERY WAS DELAYED BY APPROXIMATELY 5¿10 MINUTES; THE ADDITIONAL USE OF ANESTHESIA IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23757405 ↗
• 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 07/24/2025. 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 22792985 ↗
• MalfunctionAug 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 07/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9580-2420 24MM BASEPLATE, 20° FULL AUGMENT, AND AN AR-9582-30 MODULAR POST BECAME LOOSE AFTER 1.5 YEARS POST-IMPLANTATION. THERE WERE NO SIGNS OF INFECTION, AND THE SURGEON CONFIRMED NO HISTORY OF TRAUMA OR FALL. THE ISSUE WAS IDENTIFIED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/31/2025.

  Patient problems: Failure of Implant

  MAUDE report 22773341 ↗
• 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 (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 19940103 ↗
• MalfunctionApr 16, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-9582-30 MODULAR POST AND AN AR-9580-2420-2S AUGMENTED BASEPLATE DID NOT LOCK. SURGEON ATTEMPTED TO IMPLANT THEM MULTIPLE TIMES BUT IT WOULD NOT SEAT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: SURGEON REMOVED BOTH THE BASEPLATE AND POST FROM THE PATIENT AND USED AN AR-9580-2410-2 BASEPLATE AND AR-9582-30 MODULAR POST TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. NOTHING BROKE OFF INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19120093 ↗
• MalfunctionApr 11, 2024Defective Device; Defective Device

  ON 11/09/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9582-30 MODULAR POST AND AR-9582-2420 24 MM BASEPLATE, WOULD NOT FUSE OR TENSION TOGETHER. THIS WAS DISCOVERED ON THE BACK TABLE DURING USE IN A RTSA ON (B)(6) 2021. THE CASE WAS COMPLETED BY OPEN A NEW AR-9582-30 AND AR-9582 2420.

  Patient problems: Insufficient Information

  MAUDE report 19087170 ↗