BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA PROSTH.HEAD 12/14 36MM M

    MDR report key: 8709957 · Received June 18, 2019

    Report

    Report Number
    9610612-2019-00406
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    June 18, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    LZO
    PMA / PMN Number
    K082991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. INVESTIGATION: FAILURE DESCRIPTION: THE CERAMIC BALL HEAD SHOWS TRACES OF METAL ABRASION ON THE OUTER SURFACE AS WELL AS AT THE TAPER AREA. INVESTIGATION: THE CERAMIC BALL HEAD HAS BEEN SENT TO THE MANUFACTURER, COMPANY CERAMTEC (B)(4) IN PLOCHINGEN FOR INVESTIGATION. NO ABNORMALITIES COULD BE FOUND REGARDING THE DIMENSIONAL ACCURACY. ALL PARAMETERS ARE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. FURTHERMORE, DURING PRODUCTION ALL PARTS ARE MEASURED ON A COORDINATE MEASURING MACHINE TO MAKE SURE THAT THE DIMENSION IS ACCORDING TO THE SPECIFICATION AT EACH PART. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO FURTHER COMPLAINTS REGISTERED AGAINST THE SAME LOT NUMBER. CONCLUSION AND ROOT CAUSE: THE FAILURE IS MOST PROBABLY USAGE RELATED. THERE IS NO INDICATION FOR A PRODUCT RELATED FAILURE. RATIONALE: THE INVESTIGATION DID NOT REVEAL ANY DIMENSIONAL DEVIATION. THE CERAMIC BALL HEAD IS ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. IT IS NOT COMPREHENSIBLE WHY THE MENTIONED ISSUE OCCURRED. IT IS POSSIBLE THAT INTRAOPERATIVELY THE TAPER WAS SOILED, WHICH COULD HAVE COMPLICATED THE CORRECT FITTING OF THE BALL HEAD. NO CAPA NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT DID NOT SEAT PROPERLY. THE REPORTER INDICATED THAT IT WAS NOT POSSIBLE TO PUT THE CERAMIC BALL HEAD ON THE TAPER OF THE METAL STEM. THE BIOLOX DELTA PROSTH HEAD 12/14 36MM WAS USED IN CONJUNCTION WITH A CEMENTLESS EXCIA T SHAFT AND 12/14 CONE. DURING THE SURGERY, THE IMPLANT DID NOT APPEAR TO FIT THE CONE. ANOTHER IMPLANT OF THE SAME BATCH NUMBER WAS OPENED AND FIT WITHOUT ANY PROBLEMS. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501847 BIOLOX DELTA PROSTH.HEAD 12/14 36MM M HIP ENDOPROSTHESES - HEADS LZO AESCULAP AG NK651D 52510572

    Patients

    Seq Age Sex Outcome Treatment
    1