BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 28 SIZE M 0

    MDR report key: 11271432 · Received February 3, 2021

    Report

    Report Number
    3005180920-2021-00086
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 8, 2021
    Report Date
    February 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JANUARY 2021: LOT 100917: 50 ITEMS MANUFACTURED AND RELEASED ON 11-JUNE-2010. EXPIRATION DATE: 2015-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 20 JANUARY 2021: LINER: CC E CC LIGHT 01.26.2839HCT FLAT PE HC LINER Ø 28 / C (K103352) LOT 100724: 25 ITEMS MANUFACTURED AND RELEASED ON 06-APRIL-2010. EXPIRATION DATE: 2015-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 10 YEARS 7 MONTHS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167548 COCR BALL HEAD 12/14 28 SIZE M 0 HIP METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 100917 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention