BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITMORE HIP STEM B, SIZE 4

    MDR report key: 2090127 · Received May 6, 2011

    Report

    Report Number
    9613350-2011-00301
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THEREFORE NO TECHNICAL INVESTIGATION CAN BE ACCOMPLISHED. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WE DO NOT CONSIDER THE INCIDENT TO BE PRODUCT RELATED. 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)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS FITMORE IMPLANTED (B)(6) 2011 BY DR. (B)(6), IT WAS REVISED ON (B)(6) 2011 BY DR. (B)(6) DUE TO THE FRACTURE OF THE MEDIAL PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FITMORE HIP STEM B, SIZE 4 ZIMMER POROLOCK MIS STEM KWA ZIMMER GMBH 2544975

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization