BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    MDR report key: 3908469 · Received March 6, 2014

    Report

    Report Number
    3005673311-2014-00011
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    September 23, 2013
    Report Date
    February 14, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K060918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510 (K): K060918, K081973, K083495. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE DENSITY OF THE INSERT WAS ANALYZED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID AT TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. SECONDARY METAL TRANSFER PATTERNS WERE FOUND ON BOTH FRAGMENTS AS A RESULT OF CONTACT WITH METAL PARTS AFTER THE PRIMARY FRACTURE EVENT. PRIMARY REGULAR METAL TRANSFER AT THE CONES FROM THE CERAMIC BALL HEAD CAN BE FOUND NOT EQUALLY DISTRIBUTED AT THE WHOLE CIRCUMFERENCE. THIS MIGHT INDICATE A DISTURBANCE BETWEEN THE CERAMIC SHAFT AND THE BALL HEAD. ON THE POLISHED SURFACE AN AREA OF STIPE WEAR CAN BE FOUND. THIS GENERALLY INDICATES AN EDGE-LOADING SITUATION OR RECURRING SUBLUXATIONS. A DISTURBANCE BETWEEN THE CERAMIC SHAFT AND THE BALL HEAD AND EDGE-LOADING SITUATION OR SUBLUXATION IS A POSSIBLE ROOT CAUSE FOR THE FRACTURE OF THE CERAMIC BALL HEAD.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PATIENT NOTICED A CREAK IN THE RIGHT HIP WHILE NORMAL WALKING. AFTERWARDS THERE WAS SPONTANEOUS PAIN IN THE HIP DURING MOBILIZATION. PATIENT ASSURES, HE HAD NO FALL OR OTHER PRESSURE ON THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136384 BIOLOX PROSTHESIS HEAD 12/14 28MM S LWJ AESCULAP AG AND CO. KG NK460

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR