BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC SL SCHAFT 6 12/14

    MDR report key: 3931559 · Received June 23, 2014

    Report

    Report Number
    9613350-2014-03646
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE AFFECTED DEVICES HAVE NOT RECEIVED. FOR THE DEVICES THAT LOT NUMBERS WERE PROVIDED, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. DUE TO THE MASSIVE METALLOSIS, ARTICLE NUMBER AS WELL AS SERIAL NUMBER OF THE ALLOFIT CUP AND METASUL ALPHA INSERT WERE NOT LEGIBLE. AN E-MAIL WAS ALREADY SENT TO THE HOSP TO PROVIDE THE MISSING PRODUCT INFO, AS WELL AS PT DETAILS. ONCE THE AFFECTED PRODUCTS ARE RECEIVED AND INVESTIGATED AND THE INVESTIGATION RESULT HAS BEEN MADE AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED AN ALLOCLASSIC SL STEM 6 12/14, SOMETIME IN 2007 (EXACT DATE NOT REPORTED). ON (B)(6) 2014, THE PT UNDERWENT REVISION SURGERY DUE TO SEVERE METALLOSIS. ACCORDING TO THE SURGEON WHO PERFORMED THE REVISION SURGERY, THE ZYEMUELLER STEM NECK SHOWED STRONG SINGS OF WEAR WHICH MOST PROBABLY CAUSED BY NON-CONFORMING HEAD STEM COMBINATION (HEAD HAD CONE WAS 14/16 BUT THE STEM WAS 12/14/). AN IN-DEPTH INVESTIGATION WILL BE DONE TO CONFIRM THE CORRECT PRODUCT NUMBERS WHEN THE DEVICES ARE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364882 ALLOCLASSIC SL SCHAFT 6 12/14 ALLOCLASSIC SL STEM KWA ZIMMER GMBH 2400405

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R