BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2008936 · Received March 1, 2011

    Report

    Report Number
    9613350-2011-00107
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 28, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT EXPERIENCED PAIN AND HAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization