BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 323389 · Received March 29, 2001

    Report

    Report Number
    1822565-2001-00025
    Event Type
    Injury
    Date Received
    March 29, 2001
    Date of Event
    February 7, 2001
    Report Date
    February 12, 2001
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    3 YEARS POST OP PT. COMPLAINED OF PAIN AND INSTABILITY IN THE KNEE. PT.'S PHYSICAL EXAM SHOWED THE KNEE WAS UNSTABLE ESPECIALLY IN FLEXION. X RAYS REVEALED SLIGHT VARUS ALIGNMENT PRIMARILY AS A RESULT OF TIBIAL COMPONENT POSITIONING. ON THE FEMORAL SIDE, THE JOINT LINE HAD BEEN RAISED SOMEWHAT AND THE FEMORAL COMPONENT MIGHT HAVE BEEN A LITTLE BIT UNDERSIZED. UPON REMOVAL OF THE KNEE, THE POLYETHYLENE PORTION OF THE CCK PEG WAS FRACTURED RESULTING IN METAL ON METAL ARTICULATION.

    Description of Event or Problem · 1

    3 YEARS POST OP PT. COMPLAINED OF PAIN AND INSTABILITY IN THE KNEE. PT.'S PHYSICAL EXAM SHOWED THE KNEE WAS UNSTABLE ESPECIALLY IN FLEXION. X RAYS REVEALED SLIGHT VARUS ALIGNMENT PRIMARILY AS A RESULT OF TIBIAL COMPONENT POSITIONING. ON THE FEMORAL SIDE, THE JOINT LINE HAD BEEN RAISED SOMEWHAT AND THE FEMORAL COMPONENT MIGHT HAVE BEEN A LITTLE BIT UNDERSIZED. UPON REMOVAL OF THE KNEE, THE POLYETHYLENE PORTION OF THE CCK WAS FRACTURED RESULTING IN METAL ON METAL ARTICULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14048 ZIMMER I/B II KNEE CCK FEM LEFT, A/P JWH ZIMMER, INC. NA 78780800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention