BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM HIP GENERIC

    MDR report key: 2971958 · Received February 19, 2013

    Report

    Report Number
    9613350-2013-01360
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS VERY UNCLEAR AND NO EVENT WAS REPORTED. THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED TO DATE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. BECAUSE OF ALL THE UNCERTAINTIES OF THIS COMPLAINT IT WILL BE TREATED AS A CASE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. 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 GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP. IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM HIP GENERIC ON AN UNKNOWN DATE AND EXPERIENCED UNKNOWN SYMPTOMS. 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
    72199 DUROM HIP GENERIC DUROM HIP GENERIC LZO ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other