BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON MONO STABILIZER FEMUR

    MDR report key: 1794805 · Received August 9, 2010

    Report

    Report Number
    2249697-2010-01023
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K954138
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE FOLLOWING OTHER DEVICES ARE ALSO IMPLANTED IN THE PATIENT DURING THE PRIMARY SURGERY: DURACON UNIVERSAL B/P NON-BEADED: CAT# 6632-3-610; LOT NPVT. PS LIPPED TIBIA INSERT SM 11 6742-1-111; CAT# 00060049; LOT 00060049. DURA DURATION ALL POLY PAT SM: CAT# 6642-2-050; LOT 00092160. SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE: CAT# 6197-9-001; LOT MDL010. SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE: CAT# 6197-9-001; LOT MAL002. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S FALLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ¿THE KNEE SEEM TO BE DOING FAIRLY WELL BUT SHE IS EXPERIENCING A LOT OF FALLING SINCE HER KNEE REPLACEMENT, AND BECAUSE OF THE FALLING HER, HIP POPPED OUT. WAITING ON HIP REPLACEMENT DATE. PATIENT WAS ASKED TO SEND IN MEDICAL RECORDS AND X-RAYS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON MONO STABILIZER FEMUR IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MSRE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention