Arthrex® AR-9301-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867059931), received between Feb 7, 2025 and Sep 29, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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. How this data works · Data updated Oct 13, 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.

• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50938391 ↗
• InjuryMar 24, 2026Patient Device Interaction Problem

  ON 04-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT UNDERWENT A REVISION FROM ECLIPSE + VAULTLOCK TSA TO RTSA ON (B)(6) 2026. THE PATIENT¿S ORIGINAL SURGERY DATE WAS ON (B)(6) 2024. THE REVISION WAS PERFORMED DUE TO SUBSCAPULARIS FAILURE AND NOT DUE TO FAILURE OF THE ECLIPSE OR VAULTLOCK IMPLANTS. HOWEVER, SIGNIFICANT VAULTLOCK EROSION WAS NOTED AT LESS THAN TWO YEARS POST-IMPLANTATION. THE ARTHREX IMPLANTS EXPLANTED DURING THE REVISION INCLUDED: AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, SMALL, AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM), AR-9301-39CPC ARTHREX ECLIPSE TRUNION 39 MM, SLOTTED, TPS CAP, AND AN AR-9339-18 ARTHREX ECLIPSE HUMERAL HEAD, 39/18. ADDITIONAL INFORMATION WAS RECEIVED ON 10-MAR-2026: THE PATIENT WAS INITIALLY TREATED ON (B)(6) 2024 FOR A SUBSCAPULARIS TEAR SUSTAINED DURING A PHYSICAL ALTERCATION. DURING THE REVISION, ANTERIOR EROSION MEASURING APPROXIMATELY 2¿3 MM WAS OBSERVED. THE SURGEON DID NOT COMMENT ON WHETHER THE EROSION CONTRIBUTED TO THE NEED FOR REVISION OR IF IT WAS AN INCIDENTAL FINDING. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CASE DELAY AND NO ADDITIONAL ANESTHESIA REPORTED. NO FURTHER SURGERIE

  Patient problems: Erosion; Insufficient Information

  MAUDE report 24673781 ↗
• MalfunctionJan 15, 2026Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9301-02 ARTHREX ECLIPSE CAGE SCREW MEDIUM (35.0 MM) WOULD NOT BITE WHEN IT WAS BEING PROPERLY SIZED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08-JAN-2026: THIS OCCURRED INSIDE THE PATIENT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED WITH AN AR-9301-03 ARTHREX ECLIPSE CAGE SCREW LARGE (40.0 MM). THE CASE WAS DELAYED FIVE MINUTES, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078327 ↗
• InjuryDec 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PE INLAY AR-9121-02 OF THE UNIVERSAL GLENOID GOT WORN OFF, RESULTING IN METAL-ON-METAL CONTACT BETWEEN ECLIPSE HUMERAL HEAD AND THE BASEPLATE OF THE UNIVERSAL GLENOID. THIS RESULTED IN METALLOSE AND RELATED PROBLEMS REQUIRING A REVISION SURGERY WITH A CONVERSION TO A REVERSE PROSTEHSIS. DURING THE REVISION SURGERY THE ECLIPSE HUMERAL COMPONENTS AND THE REMAINING PARTS OF THE INLAY WERE REMOVED AND PROPER SEATING OF THE UNIVERSAL GLENOID BASEPLATE WAS CONFIRMED. THEN A GLENOSPHERE WAS INSERTED ONTO THE BASEPLATE AND THE UNIVERS REVERS HUMERAL COMPONENTS WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 23927368 ↗
• MalfunctionOct 16, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9301-02 ARTHREX ECLIPSE CAGE SCREW (MEDIUM) FAILED TO ACHIEVE ADEQUATE FIXATION FOLLOWING IMPLANTATION. ALL FIXATION WAS LOST DURING THE INITIATION OF THE SPEEDSCAP REPAIR FOR THE SUBSCAPULARIS, AND THE IMPLANT BECAME LOOSE. SUBSEQUENTLY, A LARGER-SIZED CAGE SCREW WAS IMPLANTED, WHICH PROVIDED STABLE FIXATION DESPITE THE INITIAL SIZING AS MEDIUM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED PATIENT HARM. THIS ISSUE WAS IDENTIFIED DURING AN ECLIPSE TSA PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/09/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311244 ↗
• 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 21337006 ↗