BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56

    MDR report key: 7258657 · Received February 9, 2018

    Report

    Report Number
    3005180920-2018-00030
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    January 11, 2018
    Report Date
    February 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER IMPLANTS INVOLVED ARE: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F REFERENCE 01.26.3648HCT (K103352). MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 REFERENCE 01.29.210 (K112115). THE LOT NUMBER OF THE IMPLANTS INVOLVED ARE NOT AVAILABLE

    Description of Event or Problem · 1

    REVISION DUE TO DISLOCATION OF THE HEAD 4 MONTHS AFTER PRIMARY. WHILST THE SURGEON WAS IMPLANTING A NEW HOODED INLAY, THE CUP DISLOCATED AND THERE WAS A SMALL FRACTURE AT THE ACETABULUM, SO THE VERSAFITCUP WAS REMOVED. THE REASON OF DISLOCATION WAS THAT THE CUP HAD TOO MUCH ANTEVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103534 VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention