BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BCS TIBIA BASE PLATE

    MDR report key: 2032217 · Received March 29, 2011

    Report

    Report Number
    1020279-2011-00100
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 29, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED JOURNEY TIBIA BASE PLATE HAD BONE CEMENT WELL BONDED TO THE GRIT BLASTED SURFACE. THE TIBIAL TRAY HAD SCRATCHING ON THE PROXIMAL SURFACE SOME OF WHICH WAS LIKELY DUE TO EXTRACTION. THE RETURNED JOURNEY BCS FEMORAL COMPONENT HAD BONE CEMENT WELL BONDED TO THE GRIT BLASTED SURFACE. THE FEMORAL COMPONENT HAS SCRATCHES ON THE POSTERIOR-MEDIAL AND POSTERIOR-LATERAL CONDYLES LIKELY CAUSED DURING EXTRACTION. THE POLYETHYLENE INSERT HAD DAMAGE ON THE ARTICULATING SURFACE. THESE SCRATCHES WERE LIKELY FORMED DURING EXTRACTION. THE EXACT CAUSE OF KNEE PAIN COULD NOT BE ASCERTAINED FROM THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCS TIBIA BASE PLATE JOURNEY TIBIA BASE NP RT SZ 4 JWH SMITH & NEPHEW, INC. 09BM18603

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention (B)(4)| (B)(4)