BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD 28X46

    MDR report key: 10727243 · Received October 23, 2020

    Report

    Report Number
    3005180920-2020-00741
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 27, 2020
    Report Date
    October 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843631
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 9 OCTORBER 2020 LOT 1905674: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 78 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN, 2 TWO MONTHS AFTER THE PRIMARY SURGERY, DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON REVISED THE BIPOLAR HEAD SIZE 28X46 WITH A BIPOLAR HEAD SIZE 28X46 AND THE 28MM COCR HEAD M WITH A 28MM COCR HEAD L. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195075 BALL HEADS: BIPOLAR HEAD 28X46 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2846 1905674 07630030843631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention