BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCIA PLASMAPORE-UCAP 8/10 SIZE 11MM

    MDR report key: 3217428 · Received June 21, 2013

    Report

    Report Number
    3005673311-2013-00071
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 14, 2013
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    MEH
    PMA / PMN Number
    K060437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVOLVED COMPONENTS: NJ102 (LOT #51099683). ADDITIONAL 510(K) NUMBER K081973. CERAMIC HEAD LOT OR ARTICLE NUMBER UNKNOWN (THIRD PARTY PRODUCT). THE CERAMIC INSERT IS NOT FROM AESCULAP. HIGH FRICTION CAUSED EXTREME WEAR. THIS FAILURE WAS CAUSED BY A NOT ALLOWED COMBINATION WITH COMPETITOR, WHICH IS MENTIONED IN THE IFU. OFF-LABEL USE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SURGICAL REVISION. ACCORDING TO SURGEON, THE LOOSENING BETWEEN ADAPTER AND HEAD OCCURRED BECAUSE OF THE HIGH RESISTANCE BETWEEN INLAY AND CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282418 EXCIA PLASMAPORE-UCAP 8/10 SIZE 11MM MEH AESCULAP AG & CO. KG NC411T 51090331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other