BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION KNEE

    MDR report key: 3800722 · Received May 8, 2014

    Report

    Report Number
    1644408-2014-00276
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSED OF.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS A WORN INSERT AFTER 12.5 YEARS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE (B)(4) COMPLAINT FOR A PART FROM THIS LOT. THE ROOT CAUSE FOR THE REVISION WAS MOST LIKELY NORMAL WEAR AS REPORTED. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO WEAR THE SURGEON PERFORMED A STANDARD POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279560 FOUNDATION KNEE INSERT, SLOPED SZ 8 11MM JWH ENCORE MEDICAL, L.P. 753721

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention