BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 58/52 R

    MDR report key: 2354794 · Received October 31, 2011

    Report

    Report Number
    9613350-2011-00721
    Event Type
    Other
    Date Received
    October 31, 2011
    Date of Event
    December 1, 2010
    Report Date
    October 27, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWN ESTABLISHMENT, ZIMMER INC, WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. SHOULD ADD'L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) 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 CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DUROM CUP IS LOOSE. REVISION SURGERY IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 58/52 R DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER INC 2435692

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other