BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KWA

    MDR report key: 4820669 · Received June 3, 2015

    Report

    Report Number
    9613350-2015-00639
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    March 4, 2015
    Report Date
    June 16, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE DEVICE AND INVESTIGATION IS IN PROGRESS. TWO X-RAY PICTURES WERE RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION. NO SURGICAL REPORTS OR OTHER SOURCE DOCUMENTS WERE PROVIDED FOR REVIEW. AS THE PRODUCT REFERENCE AND THE LOT NUMBERS ARE NOT YET VISIBLE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AT THAT TIME. AS SOON AS ADD'L INFO BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS IMPLANTED AN UNK METASUL HEAD (EXACT CATALOGUE NUMBER UNK) ON (B)(6) 2000. ON (B)(6) 2015, A REVISION SURGERY WAS PERFORMED DUE TO WEAR AND OSTEOLYSIS AROUND THE SCREW OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359160 KWA METASUL FEMORAL HEAD KWA ZIMMER GMBH NA 1705943

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R