BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

    MDR report key: 7446809 · Received April 20, 2018

    Report

    Report Number
    3005180920-2018-00252
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 22, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807886
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 APRIL 2018: VERSAFITCUP CC TRIO REFERENCE 01.26.45.1150 (K122911) ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 L. (B)(4). REFERENCE 01.26.3244HCT (K103352) FLAT PE HC LINER Ø 32 / E. (B)(4). AMISTEM H REFERENCE 01.18.130(K093944) HA COATED STD STEM SIZE 0. (B)(4). CERAMIC BALL HEAD (NOT MARKETED IN US): NO ANOMALY FOUND ON THE DOCUMENT REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 20 APRIL 2018. LATE INFECTION IN CEMENTLESS THA, 3 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION WITH PROPIONI BACTERIA 3 YEARS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289090 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 150073 07630030807886

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention