BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PERIPROSTHETIC DISTAL FEMUR PLATE355MM

    MDR report key: 3132975 · Received May 16, 2013

    Report

    Report Number
    9613350-2013-01577
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    December 6, 2012
    Report Date
    May 13, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AN UPDATED REPORT WILL BE SUBMITTED ONCE THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED BY THE PATIENT'S COUNSEL THAT HIS CLIENT WAS IMPLANTED AN NCB PP DIST FEM PLATE R, 18 HOLES, 'L' 355 MM ON AN UNKNOWN DATE AND UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO BREAKAGE OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218316 NCB PERIPROSTHETIC DISTAL FEMUR PLATE355MM NCB FEMUR PLATE HRS ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R