Arthrex® AR-9301-43CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867276147), received between Sep 21, 2020 and Feb 7, 2025 — classified as 2 injuries, 1 malfunction.

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

• InjuryFeb 7, 2025Break; Break

  ON 1/15/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A PATIENT REPORTED HAVING AN ARTHREX SHOULDER REPLACEMENT SURGERY ABOUT FOUR YEARS AGO. THE PATIENT REPORTED WORSENING SYMPTOMS AFTER THE SURGERY ON (B)(6) 2020. LESS THAN FOUR YEARS AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT REVISION SURGERY TO A REVERS TOTAL SHOULDER REPLACEMENT. THE PATIENT REPORTED THAT DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE GLENOHUMERAL COMPONENT WAS DAMAGED, AND ONE OF THE PEGS WAS SHEERED COMPLETELY OFF, CAUSING PAIN, SWELLING, AND PIOUS AMOUNTS OF FLUID BUILDUP. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED ON 1/23/2025. ADDITIONAL INFORMATION RECEIVED ON 1/23/025: DURING THE INITIAL SURGERY ON (B)(6) 2020, AN AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9301-02 ARTHREX ECLIPSE CAGE SCREW, AND AN AR-9301-43CPC ARTHREX ECLIPSE TRUNION WERE IMPLANTED. THE PATIENT STARTED TO EXPERIENCE PAIN AND SOUGHT OUT MEDICAL TREATMENT. THE PATIENT UNDERWENT TWO DEBRIDEMENT PROCEDURES, IN WHICH THE MISSING PEG WAS DISCOVERED. THE THIRD PROCEDURE WAS THE REVERS TOTAL SHOULDER REPLACEMENT WHICH OCCURRED ON (B)(6)2024.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21337004 ↗
• MalfunctionFeb 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2022, A NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT, LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, IS EXPERIENCING WORSENING PAIN. AN X-RAY SHOWS A DISLODGED GLENOID COMPONENT. SURGEON HAS SCHEDULED THE PATIENT FOR A REVISION SURGERY TO AN RSA ON (B)(6) 2022. ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: DURING SURGERY ON (B)(6) 2020, A TOTAL OF 4 ARTHREX DEVICES WERE IMPLANTED. AN AR-9301-03 ECLIPSE CAGE SCREW LARGE, LOT NUMBER 19.00501, AN AR-9301-43CPC ECLIPSE TRUNION, LOT NUMBER 18-01245, AN AR-9343-16 ECLIPSE HUMERAL HEAD, LOT NUMBER 1917001, AND AN AR-9106-01 UNIVERS VAULTLOCK GLENOID. AS OF NOW, NOTHING HAS SHOWN TO BE BROKEN INSIDE THE PATIENT BUT THERE'S AS DISLODGMENT OF GLENOID PROSTHESIS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: ACCORDING TO FACILITY REPRESENTATIVE, PATIENT EXPERIENCE CARDIAC EVENTS DURING THE PRE-OP AREA AND REVISION SURGERY DID NOT TAKE PLACE. AT THIS TIME, IT IS UNKNOWN IF PATIENT WILL UNDERGO REVISION SURGERY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THE REVISION SURGERY THAT WAS TO TAKE PLACE ON (B)(6) 2022, WAS CANCELLED DUE TO CARDIAC CO-MORBIDITIES. NO FURTHER INFORMAT

  Patient problems: Pain

  MAUDE report 18666775 ↗
• InjurySep 21, 2020Use of Device Problem

  IT WAS REPORTED THAT DURING AN ARTHROPLASTY TOTAL SHOULDER USING THE ECLIPSE, WHEN USING THE CENTRAL SCREW ON THE TRUNION, THE SCREW LOCKED UP, WHICH REMOVED THE CENTRAL CORE OF BONE. THEY USED THE APEX STEM TO COMPLETED THE CASE. ADDITIONAL INFORMATION OBTAINED 9/15/20: WHEN SCREWING THE CENTRAL SCREW IN THE TWO COMPONENTS LOCKED CAUSING THE TRUNION TO SPIN AND THE CORE OF BONE TO COME OFF IN THE CENTRAL SCREW. THE SURGEON THEN CHOSE TO ABORT USING THE PLANNED ECLIPSE AND INSTEAD IMPLANTED AN APEX STEM TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 10563150 ↗