BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL TRIAL HEAD

    MDR report key: 2202398 · Received August 4, 2011

    Report

    Report Number
    2249697-2011-01160
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON (B)(6), 2011, THE SALES REPRESENTATIVE CLARIFIED THE EVENT THAT THE PATIENT REPORTED. HE INDICATED THAT THE FEMORAL HEAD TRIAL FELL OFF THE NECK TRAIL INSIDE OF THE PATIENT. THE HEAD WAS REMOVED. THE PATIENT IS SUFFERING FROM NERVE DAMAGE. THE SALES REP NOTED THAT THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT HAD SURGERY ON (B)(6), 2010. THE PATIENT ALLEGED THAT A STRYKER PROTHESIS HAS CAUSED MAJOR DAMAGE TO THE FEMORAL NERVE IN HER RIGHT LEG. SHE STATED THAT SHE HAS LOST FEELING AND MOTOR CONTROL IN THIS LEG AND WALKING IS EXTREMELY DIFFICULT. SHE FURTHER INDICATED THAT SHE HAD SPENT 8 MONTHS IN PHYSICAL THERAPY USING A WALKER IN ORDER TO BE AMBULATORY AND EVEN NOW AFTER ONE YEAR, STILL HAS TO USE A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN FEMORAL TRIAL HEAD INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R| S