BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 22X43

    MDR report key: 10689619 · Received October 16, 2020

    Report

    Report Number
    3005180920-2020-00707
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 16, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843358
    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 ON 13-OCT-2020: LOT 120244: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2012. EXPIRATION DATE: 28-FEB-2017. 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 SINCE 2016. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.124 COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5 (K080885) LOT. 120541. BATCH REVIEW PERFORMED ON 13-OCT-2020: LOT 120541: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2012. EXPIRATION DATE: 28-FEB-2017. 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 SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING ACETABULAR DISCOMFORT 6 YEARS AND 6 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE DISCOMFORT IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S BIPOLAR HEAD AND THE COCR PRIMARY HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157915 BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 22X43 ACETABULAR BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 25060.2243 120244 07630030843358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention