BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP GENERIC

    MDR report key: 2922208 · Received January 15, 2013

    Report

    Report Number
    9613350-2013-01256
    Event Type
    Other
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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 CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH US DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RE-LAUNCH OF THE US DUROM CUP. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE ALLEGED USE OF A DUROM ACETABULAR COMPONENT. IT IS UNKNOWN AT THIS TIME IF THE HIP PRODUCT IS ACTUALLY A DUROM CUP. THE PATIENT RECEIVED THE IMPLANT ON (B)(6) 2008 AND IS BEING MONITORED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22250 DUROM HIP GENERIC NONE KWY ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other