BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEADS

    MDR report key: 23615344 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01165
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843679
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 NOV 2025. BALL HEADS: BIPOLAR HEAD 25060.2848 COCR BIPOLAR HEAD D 28X48 (K091967) LOT. 2410246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEPT-2024. EXPIRATION DATE: 25-AUG-2029. 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

    AFTER TWO MONTHS FROM THE PRIMARY SURGERY, THE BIPOLAR HEAD DISLOCATED FROM THE ACETABULUM. THE SURGEON REVISED THE IMPLANT, CONVERTING THE BIPOLAR SYSTEM TO A TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024013 BIPOLAR HEADS COCR BIPOLAR HEAD Ø28X48 KWY MEDACTA INTERNATIONAL SA 25060.2848 2410246 07630030843679

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention