BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABAR COMPONENT 46/40 F

    MDR report key: 1833077 · Received September 7, 2010

    Report

    Report Number
    9613350-2010-00420
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    July 29, 2009
    Report Date
    August 9, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICE 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 EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF A DEVICE DEFICIENCY CAUSING OR CONTRIBUTING TO THE REPORTED PROBLEM. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THE CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED BY PT'S COUNSEL THAT PT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6)2008. IT IS ALSO REPORTED THAT POST-OP PT EXPERIENCED PAIN, AND WAS REVISED ON (B)(6)2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABAR COMPONENT 46/40 F DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA 2392111

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R