BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP STEM

    MDR report key: 3913152 · Received June 11, 2014

    Report

    Report Number
    9613350-2014-03598
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    September 11, 2008
    Report Date
    May 20, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE 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. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO 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). THE PT HAD BILATERAL HIP IMPLANTATION. LEFT HIP REFERENCE NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP AND HAS OPTED INTO ZIMMER DUROM HIP IMPLANT CASE ACTION IN (B)(6). THIS MDR IS BEING SUBMITTED DUE TO ADD'L INFO BEING MADE AVAILABLE BY THE CLAIMANT'S COUNSEL. SHE NOW IS KNOWN TO HAVE HAD HER DUROM HIP IMPLANT ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2008 FOR A FRACTURED FEMORAL NECK AT WHICH TIME A NEW LDH WAS INSERTED. THIS MDR IS FOR THE HIP STEM, THERE IS NO FURTHER INFO ABOUT THE PERFORMANCE OF THE DUROM/LDH DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343841 UNK HIP STEM UNK HIP STEM KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R