BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITMORE HIP STEM B EXT. OFFS., SIZE 5

    MDR report key: 2359117 · Received November 11, 2011

    Report

    Report Number
    9613350-2011-00762
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    September 23, 2011
    Report Date
    October 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION 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. INITIALLY CASE WAS REPORTED BY ZIMMER INC (B)(4) WITH REPORT NUMBER 1822565-2011-02404. THIS IS A FOLLOW UP WITH AWARENESS OF THE STEM, REPORTED BY ZIMMER (B)(4). SHOULD ADDITIONAL INFORMATION 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)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT DISLOCATED AND BROKEN INSERT WAS FOUND DURING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FITMORE HIP STEM B EXT. OFFS., SIZE 5 ZIMMER POROLOCK MIS STEM KWY ZIMMER, INC. 2544991

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R