BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    MDR report key: 3931454 · Received April 14, 2014

    Report

    Report Number
    3005673311-2014-00036
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    January 29, 2013
    Report Date
    April 14, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    K060918 / K081973 / K083495. US REPORTING AGENT NOTIFIED (B)(6) 2014. EXPLANTS WERE NOT RECEIVED FOR A DETAILED INVESTIGATION. DUE TO A LACK OF FRAGMENTS AND INFORMATION ABOUT THE LASER ENGRAVING THE IDENTIFICATION OF THE COMPLAINED BALL HEAD IS ONLY POSSIBLE BASED ON THE INFORMATION PROVIDED. PROTOCOLS AND ACCEPTANCE CERTIFICATES WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE VALUES OBTAINED ON THE CERAMIC BALL HEAD WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE INSERT PROPERTIES AND THE MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PRIMARY SURGERY: 2002 RIGHT SIDE. REVISION SURGERY: (B)(6) 2014. POST OPERATIVE BREAKING OF HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226619 BIOLOX PROSTHESIS HEAD 12/14 28MM S LWJ AESCULAP AG & CO. KG NK460 51110563

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other