BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL TRAY, NON-POROUS, SZ 3

    MDR report key: 1321336 · Received February 18, 2009

    Report

    Report Number
    1722511-2009-00005
    Event Type
    Other
    Date Received
    February 18, 2009
    Date of Event
    January 12, 2009
    Report Date
    February 18, 2009
    Manufacturer
    ORTHO DEVELOPMENT CORPORATION
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AN EVALUATION OF THE DHR (INSPECTION DOCUMENTATION, WORK ORDER AND STERILIZATION PROCESSING DOCUMENTATION) DID NOT SHOW ANY REJECTIONS OR ANYTHING OUT OF THE ORDINARY CONCERNING THE MANUFACTURE AND PROCESSING OF THIS PART. THE PART WAS EXAMINED BY A KNEE PRODUCT DEVELOPMENT ENGINEER. THE EXPLANTED TIBIAL TRAY SHOWED SIGNS OF DAMAGE, WHICH IS CONSISTENT WITH THE REMOVAL OF A WELL-ADHERED IMPLANT EVEN THOUGH THERE WAS NO EVIDENCE OF BONE CEMENT ON THE IMPLANT. THE FEMORAL COMPONENT SHOWED A SIGNIFICANT AMOUNT OF BONE CEMENT AND BONE ADHERED TO THE IMPLANT. NO OTHER FORMAL REPORTS MADE TO ORTHO DEVELOPMENT DESCRIBING LOWER LEG PAIN THAT IS NOT ASSOCIATED WITH A CONFIRMED INFECTION. AT THIS POINT IT CANNOT BE DETERMINED WHY THE PATIENT WAS EXPERIENCING LEG PAIN. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT WAS DESCRIBING LOWER LEG PAIN. TIBIAL TRAY, FEMORAL COMPONENT AND TIBIAL INSERT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL TRAY, NON-POROUS, SZ 3 KNEE IMPLANT HSH ORTHO DEVELOPMENT CORPORATION 162-1300 82021

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization