BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCIA CEMENTED 8/10 SIZE 12MM

    MDR report key: 2860343 · Received November 5, 2012

    Report

    Report Number
    3005673311-2012-00098
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Report Date
    October 3, 2012
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    JDI
    PMA / PMN Number
    K042344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNITED STATES AGENT NOTIFIED (B)(4) 2012. PMA/510(K) K081973. EVALUATION: QUALITY DOCUMENTS CHECKED, NO DEVIATIONS FOUND. PRODUCT WAS MANUFACTURED IN 02/2007. IN 01/2008 THE PACKAGING OF THIS PRODUCT WAS NEWLY VALIDATED AND IMPROVED. NO COMPLAINTS WITH THIS ERROR SINCE THE NEW PACKAGING HAS BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6) . (B)(6) 2012, A PT SHOULD HAVE BEEN SUPPLIED WITH AN EXCIA SHAFT 12 CEMENTED. AFTER OPENING THE OUTER PACKAGE IT WAS NOTICED, THAT THE DISTAL END OF THE PROSTHESIS HAD JACKED BOTH STERILE PACKAGING AT THE WELDING SEAM. THE PT WAS SUPPLIED WITH A SMALLER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCIA CEMENTED 8/10 SIZE 12MM JDI AESCULAP AG & CO. KG NJ312K 51368378

    Patients

    Seq Age Sex Outcome Treatment
    1