BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS KNEE

    MDR report key: 120689 · Received September 16, 1997

    Report

    Report Number
    MW1012096
    Event Type
    Injury
    Date Received
    September 16, 1997
    Date of Event
    June 22, 1995
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATELLA AND THE PLUS KNEE, SIZE LARGE PROSTHESIS WERE INSERTED IN RPTR'S LEFT LEG. ON JUNE 22, 1995, RPTR UNDERWENT A SO-CALLED EXPLORITORY OPERATION OF THE LEFT KNEE PROSTHESIS TO DETERMINE THE CAUSE OF CONSTANT PAIN AND SWELLING. DURING THE OPERATION, WHEN THE PATELLA WAS EVERTED, THE PLASTIC COMPONENT OF THE PATELLA FELL LOOSE INTO THE SURGEONS HANDS. THE METAL DISC, WITH NATURAL KNEE CAP WERE REMOVED AND SUPPOSEDLY REPLACED WITH "A GLUED IN PLASTIC PIECE AND THE SAME NATURAL KNEE CAP. RPTR IS NOT SURE IF THE REPLACEMENT REVISION WAS CORRECT, OR IF IT MET WITH FDA APPROVAL. RPTR IS SUFFERING WITH THE SAME PAIN AND SWELLING THAT THEY HAD PRIOR TO UNDERGOING THE SO-CALLED EXPLORITORY OPERATION. RPTR HAS SOUGHT MEDICAL ATTENTION AND HAS BEEN ADVISED THAT NOTHING CAN BE DONE FURTHER, SINCE THE KNEE HAS UNDERGONE TOO MUCH WORK (ONE ARTHROSCOPIC PLUS TWO MAJOR OPERATIONS. THE DEFECTIVE PARTS, REMOVED FROM RPTR'S KNEE, ARE IN RPTR'S POSSESSION. UPON EXAMINING THEM, RPTR FOUND THE REASON WHY THE PLASTIC COMPONENT HAD SEPARATED FROM THE METAL DISC. THE EXTENSION ON THE PLASTIC PIECE, WHOSE PURPOSE IS TO ENGAGE THE INTERIOR OF THE TUBULAR SECTION OF THE METAL PIECE, TO PERMANENTLY HOLD THE TWO PATELLAR COMPONENTS TOGETHER, WAS COMPLETELY FRACTURED. THIS BROKEN EXTENTION WAS FOUND LODGED IN THE INTERIOR OF THE METAL TUBULAR SECTION. RPTR BELIEVES THERE TO BE FUNDAMENTAL DESIGN FLAW IN ORTHOMETS PATELLA PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS KNEE Implant LARGE SIZE PATELLA PROSTHESIS HTG WRIGHT MEDICAL TECHNOLOGY, INC. * 002679001

    Patients

    Seq Age Sex Outcome Treatment
    1 *