BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 J

    MDR report key: 2922211 · Received January 15, 2013

    Report

    Report Number
    9613350-2013-01261
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    August 22, 2013
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS VERY UNCLEAR. THE REPORT DID NOT MENTION IF THE PRODUCT IS A ZIMMER PRODUCT AND NO EVENT WAS REPORTED. SINCE THE IMPLANT DATE IS UNKNOWN WE CONSIDER THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED ABOVE. HOWEVER, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVALUATION 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 PATIENT, THROUGH COUNSEL, IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE ALLEGED USE OF THE DUROM ACETABULAR COMPONENT. THE PATIENT RECEIVED A HIP IMPLANT ON AN UNKNOWN DATE DUE TO UNKNOWN SYMPTOMS. IT IS UNKNOWN AT THIS TIME IF THE HIP PRODUCT IS ACTUALLY THE DUROM CUP AND IF IT IS A ZIMMER PRODUCT. IT IS FURTHER UNKNOWN IF A REVISION SURGERY IS IN DISCUSSION OR HAS TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22251 DUROM ACETABULAR COMPONENT 50/44 J DUROM ACETABULAR COMPONENT AND METASUL KWY ZIMMER GMBH 2432815

    Patients

    Seq Age Sex Outcome Treatment
    1 43 DA Female Other| H| R