BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X45

    MDR report key: 11193068 · Received January 19, 2021

    Report

    Report Number
    3005180920-2021-00053
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843617
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JANUARY 2021 LOT 1905682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON "23-OTT-2019". EXPIRATION DATE: 2024-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO BIPOLAR HEAD LUXATION FROM THE ACETABULUM, 19 DAYS AFTER THE PRIMARY. THE SURGEON REVISED THE BIPOLAR HEAD AND COCR HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89753 BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 28X45 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2845 1905682 07630030843617

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention