BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 12/14 32MM L

    MDR report key: 3908047 · Received March 6, 2014

    Report

    Report Number
    3005673311-2014-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    March 16, 2013
    Report Date
    January 2, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K060918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K081973, K083495. US REPORTING AGENT NOTIFIED ON (B)(4) 2013. MANUFACTURING SITE EVALUATION: NO PRODUCT RECEIVED FOR A DETAILED INVESTIGATION. THE COMPLAINED BALL HEAD WAS PART OF SHOP ORDER (B)(4). PROTOCOLS AND ACCEPTANCE CERTIFICATE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE VALUES OBTAINED ON THE BALL HEAD WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE BALL HEAD 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. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CAN NOT BE DONE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). ACCORDING TO THE INCIDENT REPORT, A BROKEN CERAMIC JOINT HEAD GAVE RISE TO REVISION TO NEW HIP PROSTHESIS. IT IS STATED THAT THE INCIDENT DATE IS (B)(6) 2005, BUT THIS MIGHT BE THE INITIAL IMPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137095 BIOLOX PROSTHESIS HEAD 12/14 32MM L LWJ AESCULAP AG AND CO. KG NK562 51210987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other