BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURO TIBIAL COMP. OFFSET CEMENTED T1

    MDR report key: 3944277 · Received May 8, 2014

    Report

    Report Number
    3005673311-2014-00052
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K101815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE MENISCUS COMPONENT SHOWS WEAR ON THE UPPER AND BOTTOM SIDES. THE OTHER COMPONENTS DO NOT SHOW ANY ABNORMALITIES. THE FEMUR AND TIBIA COMPONENTS SHOW ADHESIVE BONE CEMENT WITH IMPRINT OF THE SPONGIOSE BONE. THIS INDICATES BONE WAS ADHERED WITH THE IMPLANT AND THE BONES AS IT SHOULD BE. ALL MANUFACTURING FILES REGARDING THESE BATCHES WERE CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION. THERE ARE NO OTHER COMPLAINTS REGARDING THIS BATCH. THERE ARE NO INDICATIONS OF MATERIAL OR PRODUCTION FAILURE. THE WEAR ON THE INLAY IS LIKELY CAUSED BY THIRD BODY WEAR. THE LOOSENING WAS LIKELY DUE TO THE INFECTION (PATIENT RELATED).

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). AN ENDURO KNEE WAS IMPLANTED 2 YEARS AGO. IT HAD TO BE EX PLANTED DUE TO INFECTION. SURGEON NOTICED HEAVY ABRASION ON THE TIBIA INLAY. INVOLVED COMPONENTS: NB018K - 51833282, NR880M - 51825077.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278079 ENDURO TIBIAL COMP. OFFSET CEMENTED T1 KNEE ENDOPROTHESIS KRO AESCULAP AG & CO. KG NB011K 51832485

    Patients

    Seq Age Sex Outcome Treatment
    1 Other