BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX PROSTHESIS HEAD 12/14 28MM M

    MDR report key: 2565509 · Received April 27, 2012

    Report

    Report Number
    3005673311-2012-00029
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    February 9, 2012
    Report Date
    April 18, 2012
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K060918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    U.S. DIVISION NOTIFIED (B)(6) 2012. U.S. DOES NOT SELL CERAMIC (WHICH WAS THE INDICATION USED FOR THIS CASE); HOWEVER, WE DO SELL THIS IMPLANT. WE DO NOT ANTICIPATE A REPEAT ISSUE DUE TO DIFFERENT USAGE CIRCUMSTANCES. ADD'L 510 (K): K081973, K083495. HEAD AND CAP WERE RETURNED. PRELIMINARY REPORT INDICATES THERE ARE SIGNS OF A TILTED IMPLANTATION OF THE BALL HEAD ON THE STEM. THE MFG AND QUALITY RECORDS SHO NO DIVERGENCES. NO INDICATION, FROM THE INVESTIGATION, FOR A MFR MISTAKE OR MATERIAL DEFECT.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INITIAL SURGERY (B)(6) 2004. CURRENTLY THE NORMAL-WEIGHTY PT HAD TO BE REVISED BECAUSE OF THE BREAK OF THE HEAD NK461. THE CAUSE OF FRACTION IS UNCLEAR, THERE WAS NO FALL OR ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX PROSTHESIS HEAD 12/14 28MM M LWJ AESCULAP AG & CO. KG NK461 51185886

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other