BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILOX PROSTHESIS HEAD 12/14 28MM L

    MDR report key: 3877267 · Received May 23, 2014

    Report

    Report Number
    3005673311-2014-00053
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 23, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K060918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVAL: AWAITING PRODUCT RETURN. ADD'L 510(K): K081973 AND K083495.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SPONTANEOUS POST OPERATIVE INSERT BREAKING ON THE RIGHT SIDE. RADIOLOGICALLY VISIBLE; CRUSHED CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308646 BILOX PROSTHESIS HEAD 12/14 28MM L HIP ENDOPROTHESIS. LWJ AESCULAP AG AND CO. KG NK462 512504258

    Patients

    Seq Age Sex Outcome Treatment
    1 Other