BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1853240 · Received September 30, 2010

    Report

    Report Number
    1644408-2010-00513
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY DISCOMFORT AFTER 3.2 YEARS OF PT USE. THE CAUSE FOR THIS DISCOMFORT WAS REPORTED AS AN UNDERSIZED TIBIA, AND THE PT HAS HEALTH PROBLEMS AND IS OBESE (ACTUAL WEIGHT NOT PROVIDED WITH THE COMPLAINT). THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE SIZE CHANGES WERE MOST LIKELY A RESULT OF THE REVISION SURGERY WHERE LARGER SIZES ARE NEEDED DUE TO BONE REMOVAL DURING EXTRACTION. HEALTH PROBLEMS AND OBESITY CAN CONTRIBUTE TO PAIN AND CAUSE THE PT DISCOMFORT.

    Description of Event or Problem · 1

    REVISION SURGERY - PT EXPERIENCING DISCOMFORT, UNDERSIZED TIBIA, THE PT HAS HEALTH PROBLEMS AND IS OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSERT JWH ENCORE MEDICAL, L.P. 53778329

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 320-15-502, LOT 53778329| 321-01-102, LOT 466032