BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS FEM ROT HNGE LFT 65MM BOD

    MDR report key: 3924408 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02595
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K972401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MATERIAL ANALYSIS WAS PERFORMED ON THE STEM AND CONCLUDED THAT THE FEMORAL STEM FRACTURED IN FATIGUE THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED REVISION SURGERY DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. THE CLINICAL INDICATION FOR THE REVISION WAS NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 2481-3-080, MRS FEM W/MALE-FE TAPER 80 BD, LOT CODE: BSIRC; CAT. NO: UNK, UNKNOWN TIBIAL ROTATING COMPONENT, LOT CODE: UNK ; CAT. NO: UNK, UNKNOWN AXLE, LOT CODE: UNK; CAT. NO: UNK, UNKNOWN CEMENTED STEM, LOT CODE: UNK; CAT. NO: UNK, UNKNOWN BUMPER, LOT CODE: UNK; CAT. NO: UNK, UNKNOWN FEMORAL BUSHINGS, LOT CODE: UNK. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON (B)(6) 2014 DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401039 MRS FEM ROT HNGE LFT 65MM BOD IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention