BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY JDK TENSIONING

    MDR report key: 4559560 · Received March 2, 2015

    Report

    Report Number
    0002249697-2015-00504
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE COULD NOT BE OBTAINED AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALANCER WAS FUNCTIONAL DURING BALANCING WITH EXTENDED POSITION OF KNEE(20LBS). WHEN THE SURGEON USED THE BALANCER DURING BALANCING WITH FLEXION POSITION OF KNEE(20LBS), THE RACHET OF THE BALANCER WAS NOT FUNCTIONAL. THE RACHET COULD NOT BE FIXED. THE RATCHET COULD BE FIXED WHEN 40 LBS WAS ADDED IN FLEXION POSITION OF KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143568 SPECIALTY JDK TENSIONING INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other