BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 2227424 · Received August 17, 2011

    Report

    Report Number
    9613350-2011-00541
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. UNFORTUNATELY NO FURTHER INFO WAS PROVIDED FOR INVESTIGATION. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) 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 CLOSED. (B)(6).

    Description of Event or Problem · 1

    IT IS REPORTED THAT X-RAY SHOWED RESURFACING COMPONENTS WITH A LOOSE ACETABULAR COMPONENT. PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER, INC. 2418287

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R