BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 25185342 · Received May 15, 2026

    Report

    Report Number
    3005180920-2026-00462
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040712675
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15-MAY-2026 ANATOMICAL SHOULDER SYSTEM 04.01.0029 HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135° -12 (K170910) LOT. 167953A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2017. EXPIRATION DATE: 2022-MAR-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.TWO ITEMS WERE RESTERILIZED, AND TO DATE, ONE UNIT HAS BEEN SOLD. ANATOMICAL SHOULDER SYSTEM 04.01.0094 METAL HUMERAL HEAD D 48 (K170910) LOT. 2349427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2024. EXPIRATION DATE: 2029-APR-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT. 2418711: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2024. EXPIRATION DATE: 2029-AUG-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 YEAR AND MONTH AFTER LAST REVISION SURGERY. THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2024, FOLLOWED BY THREE REVISION SURGERIES PRIOR TO THE CURRENT PROCEDURE. THE SURGEON REMOVED ALL IMPLANTS AND PLACED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87932 ANATOMIC SHOULDER PROSTHESIS HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-12 KWS MEDACTA INTERNATIONAL SA 04.01.0029 167953A 07630040712675

    Patients

    Seq Age Sex Outcome Treatment
    1