BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUADRA C CEMENTED STEM SIZE 3 STD

    MDR report key: 3080786 · Received April 12, 2013

    Report

    Report Number
    3006639916-2013-00036
    Event Type
    Other
    Date Received
    April 12, 2013
    Manufacturer
    MEDACTA USA INC.
    Product Code
    LZO
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 28 MONTHS POST-OP, ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER INSERTED VIA POSTERIOR APPROACH. PLEASE REFERENCE MFR REPORT # 3005180920-2013-00036.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157816 QUADRA C CEMENTED STEM SIZE 3 STD CEMENTED FEMORAL STEM LZO MEDACTA USA INC. 121756

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CERAMIC HEAD AND LINER, NOT MARKETED IN THE USA.| VERSAFITCUP CC LIGHT CUP, NOT MARKETED IN THE USA.