BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HARRIS-GALLANTE HIP

    MDR report key: 4780369 · Received May 14, 2015

    Report

    Report Number
    1822565-2015-00705
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 13, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS REPORTED THAT A DEPUY ACETABULAR SYSTEM WAS USED WITH A ZIMMER FEMORAL STEM AND HEAD. ZIMMER HAS NOT TESTED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. THE PART AND LOT NUMBERS OF THE PRODUCTS ARE UNKNOWN; THEREFORE THE MANUFACTURING RECORDS, AND COMPLAINT HISTORY COULD NOT BE REVIEWED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT HIP ARTHROPLASTY IN 1985 FOR PLACEMENT OF A ZIMMER FEMORAL STEM AND HEAD, AND SUBSEQUENT PROCEDURE IN (B)(6) 1995 FOR PLACEMENT OF DEPUY ACETABULAR COMPONENTS. THE PATIENT DISLOCATED AND WAS REVISED ONE MONTH LATER IN (B)(6) 1995.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316959 UNKNOWN ZIMMER HARRIS-GALLANTE HIP HIP PROTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention