BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 8/10 32MM M

    MDR report key: 3217423 · Received June 21, 2013

    Report

    Report Number
    3005673311-2013-00067
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    March 12, 2013
    Report Date
    June 10, 2013
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LZO
    PMA / PMN Number
    K042344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US AGENT NOTIFIED (B)(4) 2013. ADDITIONAL 510(K) NUMBER K081973. EVALUATION: THE DEVICE HISTORY RECORD HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT TIME OF PRODUCTION. THERE ARE NO INDICATIONS FOR A MANUFACTURING- OR MATERIAL DEFECT. THE HEAD PROPERTIES AND THE MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENT AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. IT APPEARS FROM THE SURGICAL REPORTS, THAT THE HEAD WAS COMBINED WITH AN INLAY FROM THE MANUFACTURER ESKA. THIS COMBINATION IS NOT APPROVED BY AESCULAP AND NOT ALLOWED. INVOLVED COMPONENTS: NJ107 - LOT 51125115; EXCIA-SCHAFT - LOT UNK; ESKA-CUP - NO AESCULAP PRODUCT; ESKA-CERAMIC-INLAY - NO AESCULAP PRODUCT. THE FAILURE WAS CAUSED BY AN NOT ALLOWED COMBINATION WITH COMPETITOR, WHICH IS MENTIONED IN THE IFU. OFF-LABEL USE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). POST OPERATIVE BREAKAGE OF A CERAMIC HEAD. LEFT HIP. PRIMARY SURGERY: (B)(6) 2002. REVISION SURGERY: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281826 BIOLOX PROSTHESIS HEAD 8/10 32MM M LZO AESCULAP AG & CO. KG NJ107 51125115

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other