BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP GENERIC

    MDR report key: 2922221 · Received January 15, 2013

    Report

    Report Number
    9613350-2013-01239
    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
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NEITHER ARTICLE NOR LOT NUMBER IS KNOWN, THE REVIEW OF THE QUALITY RECORDS COULD NOT BE PERFORMED. SINCE THE IMPLANT DATE IS UNK ZIMMER CONSIDERS THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED ABOVE. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICES BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE PT, THROUGH COUNSEL, IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE ALLEGED USE OF THE DUROM ACETABULAR COMPONENT. THE PT RECEIVED AN IMPLANT ON (B)(6) 2006, BUT IT IS UNK AT THIS TIME IF THE HIP PRODUCT IS ACTUALLY THE DUROM CUP. IT IS FURTHER UNK IF THE PRODUCTS WILL BE RETURNED TO ZIMMER. THE PT IS CURRENTLY BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21671 DUROM HIP GENERIC DUROM HIP GENERIC KWY ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other