BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA CLAMP

    MDR report key: 1941012 · Received December 7, 2010

    Report

    Report Number
    2249697-2010-01663
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RESULTS OF THE INVESTIGATION INDICATE THAT WIDTH OF THE LOCKING TRIGGER IS NOT ADEQUATE AND CREATES A POINT CONTACT WITH THE LOCKING TEETH. WEAR ON THE LOCKING TRIGGER AND/OR THE LOCKING TEETH RESULTS IN LOSS OF FRICTION AT THE CONTACT POINT, WHICH CAUSES THE PAWL-TEETH ASSEMBLY TO LOSE FUNCTION, SPRINGING THE CLAMP OPEN. VISUAL INSPECTION INDICATED THAT THE DEVICE WAS RETURNED IN USED CONDITION. OPTICAL INSPECTION INDICATED THAT THE TEETH OF THE LOCKING MECHANISM ARE WORN. THE RETURNED DEVICE HAS THE THINNER LOCKING TRIGGER TIP, INDICATING IT WAS MANUFACTURED BEFORE DESIGN CHANGE WAS IMPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATELLA CLAMP WOULD NOT STAY LOCKED DURING CEMENTING OF PATELLA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATELLA CLAMP INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA CZS03B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other