BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HEAD Ø28X46

    MDR report key: 8252592 · Received January 16, 2019

    Report

    Report Number
    3005180920-2018-01099
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 17, 2018
    Report Date
    January 16, 2019
    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 ON 14 JANUARY 2019: LOT 180438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2018. EXPIRATION DATE: 2023-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 28 SIZE M 0 REFERENCE 01.25.012 (K072857): LOT 183115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2018. EXPIRATION DATE: 2023-07-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 1 MONTH AFTER PRIMARY FOR AN INFECTION CASE THE SURGEON SURGEON WASHED OUT THE HIP AND REVISED THE BIPOLAR HEAD AND COCR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44681 BIPOLAR HEAD Ø28X46 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 180438 07630030843631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention