BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEADS

    MDR report key: 24581578 · Received March 12, 2026

    Report

    Report Number
    3005180920-2026-00180
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843792
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 FEB 2026. BALL HEADS: BIPOLAR HEAD 25060.2854 316LVM BIPOLAR HEAD D 28 X 54 (K091967) LOT 2503841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2025. EXPIRATION DATE: 2030-MAY-27. 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: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT EXPERIENCED A HIP DISLOCATION (BIPOLAR FROM THE ACETABULUM) AND, DURING THE ATTEMPT TO PERFORM A CLOSED REDUCTION AT THE HOSPITAL, THE BIPOLAR HEAD DISSOCIATED FROM THE 28 MM FEMORAL HEAD. AN OPEN REDUCTION WAS THEN PERFORMED. THE SURGEON REVISED THE BIOLOX HEAD TO A HEAD OF THE SAME SIZE AND THE BIPOLAR HEAD TO A HEAD OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643604 BIPOLAR HEADS 316LVM BIPOLAR HEAD Ø28 X 54 KWY MEDACTA INTERNATIONAL SA 25060.2854 2503841 07630030843792

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention