BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM FEMORAL COMPONENT 52 CODE R

    MDR report key: 3221545 · Received July 9, 2013

    Report

    Report Number
    9613350-2013-01714
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 12, 2007
    Report Date
    June 28, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVED DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM FEMORAL COMPONENT 52 CODE R ON THE RIGHT SIDE ON (B)(6) 2006. DUE TO PAIN, THE PATIENT WAS REVISED ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313732 DUROM FEMORAL COMPONENT 52 CODE R DUROM FEMORAL COMPONENT KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R