BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KX+ DURATION PATELLA MED

    MDR report key: 3875099 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02285
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    January 1, 2010
    Report Date
    March 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K071991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING AN KINEMAX PATELLA COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED, THE COMPONENTS REMAIN IMPLANTED. DHR REVIEW WAS SATISFACTORY. THERE HAVE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. THE REPORTED PAIN WAS CONFIRMED THROUGH THE MEDICAL RECORDS PROVIDED. THE MEDICAL REVIEW INDICATED THAT THE PATIENT HAD EXCELLENT RANGE OF MOTION AND THE COMPONENTS POSITION WAS GOOD. THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS RESPONSIBLE FOR THIS CLINICAL SITUATION. THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A CAPA TREND ANALYSIS WAS CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARS LOTS OF POPPING AND SCRATCHING SOUND LIKE METAL IN BOTH LEFT AND RIGHT KNEE. PATIENT ALSO HAS PAIN TIME TO TIME IN BOTH KNEES. HE IS CONCERNED IF HIS IMPLANT IS PART OF THE RECALL PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARS LOTS OF POPPING AND SCRATCHING SOUND LIKE METAL IN BOTH LEFT AND RIGHT KNEE. PATIENT ALSO HAS PAIN TIME TO TIME IN BOTH KNEES. HE IS CONCERNED IF HIS IMPLANT IS PART OF THE RECALL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352074 KX+ DURATION PATELLA MED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBE516

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other