BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATROLOC FEM REV STEM W/O LATERAL SHOULDER

    MDR report key: 3233919 · Received July 16, 2013

    Report

    Report Number
    1932213-2013-00001
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    WHITESIDE BIOMECHANICS (NOW SIGNAL MEDICAL)
    Product Code
    LPH
    PMA / PMN Number
    K964616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    GENTLEMAN HAD A SHARP PAIN IN HIS HIP AFTER WALKING OR JOGGING LIGHTLY ON A TREADMILL. HE WAS BROUGHT INTO THE EMERGENCY ROOM BECAUSE HE WAS HAVING A LOT OF PAIN AND COULD NOT GET BACK UP AND WALK ON IT. PATIENT DOES NOT RECALL ANY SPECIFIC TRAUMA OTHER THAN BEING ACTIVE ON HIS TREADMILL WHEN HE FIRST STARTED TO HAVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329516 QUATROLOC FEM REV STEM W/O LATERAL SHOULDER HIP STEM LPH WHITESIDE BIOMECHANICS (NOW SIGNAL MEDICAL) R2S-200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention