BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICONTACT S COCR CEMENTED 12/14 SZ.10MM

    MDR report key: 2554752 · Received April 5, 2012

    Report

    Report Number
    3005673311-2012-00011
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Report Date
    February 29, 2012
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED BY AESCULAP IMPLANT SYSTEMS (AIS) IN THE UNITED STATES; HOWEVER, SIMILAR DEVICES ARE MARKETED BY AIS. MANUFACTURING FACILITY CHECKED THE DEVICE HISTORY RECORDS WITH NO INDICATION OF PRODUCT OR MATERIAL DEFECT. THERE ARE NO FURTHER SIMILAR INCIDENTS REPORTED FOR THIS PRODUCT TO DATE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6), IMPLANTATION: 2006. FRACTURE OF STEM (RIGHT SIDE) WAS DISCOVERED INCIDENTALLY WHEN PATIENT WAS PREPARED FOR LEFT SIDE SURGERY. PATIENT (B)(4)WILL BE (B)(6) YRS THIS YEAR, SHE IS NORMAL WEIGHT AND SMALL BODY HEIGHT. MEANWHILE A CEMENTED STEM (SIZE 12) HAS BEEN IMPLANTED, LEFT SIDE. FRACTURE OF THE STEM, RIGHT SIDE, IS UNCOMPLAINING. X-RAYS SHOW BEGINNING HYPERTROPHY OF CORTICAL SUBSTANCE OF BONE. PATIENT REFUSES REVISION SURGERY AS LONG AS SHE DOES NOT SUFFER ANY PAIN. RELATIVES OF PATIENT WERE INFORMED CONCERNING THE FRACTURE OF THE PROSTHESIS. PATIENT'S CONDITION WILL BE MONITORED BY DOCTOR. PATIENT WILL BE APPROPRIATELY REFERRED WHEN / IF SHE AGREES TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICONTACT S COCR CEMENTED 12/14 SZ.10MM NONE LWJ AESCULAP AG & CO. KG NK610K 51298803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other