Arthrex® AR-9301-45CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867276154), received between Aug 11, 2021 and Mar 12, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 2/17/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A RUPTURED SUBSCAPULARIS DUE TO A TRAUMATIC FALL. THE PATIENT UNDERWENT REVISION SURGERY OF THE ANATOMIC SHOULDER REPLACEMENT TO A REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2023. THE EVENT WAS INDICATED AS UNRELATED TO THE ECLIPSE SYSTEM IMPLANTED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 2/27/2025: ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE AN AR-9301-45CPC ARTHREX ECLIPSE TRUNION, AN AR-9106-02 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE, AND AN AR-9345-17 ARTHREX ECLIPSE HUMERAL HEAD REMOVED. AFTER THE SURGERY, THE PATIENT IS DOING WELL WITH AN EIGHTY-FIVE TO NINETY PERCENT IMPROVEMENT IN SYMPTOMS.

  Patient problems: Failure of Implant

  MAUDE report 21586152 ↗
• MalfunctionJan 13, 2025Positioning Failure; Positioning Failure

  ON 12/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM DID NOT GET SUFFICIENT FIXATION WITH THE ECLIPSE TRUNION AND CAGE SCREW. THE CASE WAS COMPLETED USING A LONG STEM. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/30/2024: THE PART NUMBERS AR-9301-02 AND CAGE SCREW AND AR-9301-45CPC ARTHREX ECLIPSE TRUNION WERE PROVIDED. ADDITIONALLY, THE SALES REPRESENTATIVE REPORTED THAT ANOTHER AR-9400-SBK ECLIPSE SPEEDSCAP IMPLANT SYSTEM FROM A DIFFERENT LOT NUMBER AND AN AR-9301-01 ARTHREX ECLIPSE CAGE SCREW WAS ATTEMPTED TO BE USED AS WELL BUT STILL COULD NOT GET SUFFICIENT FIXATION. THE CASE WAS COMPLETED USING AN AR-9100-05M UNIVERS APEX OPTIFIT HUMERAL STEM. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21136741 ↗
• InjuryAug 11, 2021Positioning Problem

  IT WAS REPORTED DURING A TOTAL SHOULDER ARTHROPLASTY, WHEN THE SURGEON WAS GOING TO USE THE ECLIPSE, IT WAS NOT SITTING WELL AND THE SURGEON DIVERTED TO AN UNIVERS HEAD AND APEX STEM. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306237 ↗