Arthrex® AR-9580-2410Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867341630), received between Mar 15, 2021 and Jan 13, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Fitting Problem; Fitting Problem

  ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9580-2410 UNIVERS REVERS MODULAR GLENOID SYSTEM AUGMENTED BASEPLATE AND AN AR-9582-20 MODULAR POST FOR AUGMENTED MGS BASEPLATE WOULD NOT ENGAGE WITH THE TAPER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024 .

  Patient problems: Insufficient Information

  MAUDE report 21138062 ↗
• 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 (B)(6) 2022 DURING A REVERS TOTAL SHOULDER ARTHROPLASTY WHEN THE (B)(4) 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 19267499 ↗
• MalfunctionNov 2, 2023Defective Device; Defective Device

  ON 10/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9582-20 MODULAR POST, 20MM, AND AN AR-9580-2410 24MM BASEPLATE WERE NOT LOCKING TOGETHER DURING A PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME DEVICES WITH NO REPORTED DELAY IN THE PROCEDURE. THIS WAS DISCOVERED DURING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE ON 10/9/2023 WITH NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054452 ↗
• 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 15577555 ↗
• InjuryJun 7, 2021Loose or Intermittent Connection; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO DO A 10 DEGREE AUGMENTED MGS GLENOID WITH A 35MM CENTRAL POST. AFTER IMPACTING THE GLENOSPHERE ONTO THE BASEPLATE, THE PATIENT'S GLENOID FRACTURED AND THE ENTIRE CONSTRUCT CAME LOOSE (SEE ATTACHED PICTURE). THE SURGEON WAS NOT SURE IF THEY WERE TOO ANTERIOR WITH THEIR INITIAL GUIDE PIN AND SUBSEQUENT REAMING, POSSIBLY WEAKENING THE BONE ANTERIORLY. THE SURGEON ALSO WENT BI-CORTICAL IN THE VAULT WITH THE CENTRAL POST (B)(4)) AND DID NOT KNOW IF THIS ULTIMATELY LED TO THE FAILURE. THE SURGEON WAS ABLE TO USE BONE GRAFT FROM THE PATIENT'S RESECTED HUMERAL HEAD TO ADDRESS THE GLENOID FRACTURE AND THEN IMPLANTED A NON-AUGMENTED MGS BASEPLATE AND FINISHED THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11946802 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PULMONARY EMBOLISM RESULTING IN INPATIENT HOSPITALIZATION OCCURRED DURING A SHOULDER ARTHROPLASTY PROCEDURE IN WHICH ARTHREX PRODUCT WAS BEING USED. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION. THE FACILITY REPORTED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS RECOVERING.

  Patient problems: Pulmonary Embolism

  MAUDE report 11484215 ↗