BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 201251 · Received December 8, 1998

    Report

    Report Number
    201251
    Event Type
    Injury
    Date Received
    December 8, 1998
    Date of Event
    November 10, 1998
    Report Date
    November 24, 1998
    Manufacturer
    WRIGHT MEDICAL PROD.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT TOTAL KNEE IMPLANT 10/30/1998. TIBIAL POLYETHYLENE TRAY LOCKED INTO POSITION. 10 DAYS POST-OP PT BENT OVER, FELT LARGE "POP" & SEVERE PAIN (2) KNEE. TO ER X-RAY SHOWED DISLOCATED TRAY. 11/10/1998 PT TO SURGERY. TRAY WAS FOUND TO BE UNLOCKED & ANTERIOR SUBLEXED. FOUND 1 X 2 MM PIECE BONE CEMENT LODGED BETWEEN POSTERIOR LOCKING MECHANISM & TIBIAL IMPLANT. TRAY WAS REPLACED AT THIS TIME WITH ANOTHER FROM SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant KNEE IMPLANT JWH WRIGHT MEDICAL PROD. * 078A084392
    2 *
    3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention