BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR FINNED STEM

    MDR report key: 2510916 · Received March 27, 2012

    Report

    Report Number
    2510916
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    BIOMET ORTHOPEDICS, LLC
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 3 1/2 YEARS AGO, THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY FOR SEVERE DEGENERATIVE JOINT DISEASE, PRIMARILY IN THE LATERAL AND PATELLOFEMORAL COMPARTMENTS. PATIENT HAS CONTINUED HAVING PAIN. RETURNED TO OR TO HAVE KNEE HARDWARE REMOVED AND REPLACED DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR FINNED STEM MODULAR FINNED STEM JWH BIOMET ORTHOPEDICS, LLC 141314 450480
    2 PRIMARY TIBIAL PLATE PRIMARY TIBIAL PLATE JWH BIOMET 141211 438870
    3 MAXIM PS TI FEMORAL WITH UNIVERSAL FLANGE MAXIM PS TI FEMORAL WITH UNIVERSAL FLANGE JWH BIOMET CP110061 583790
    4 DCM MAXIM PS TIBIAL BEARING 10MM X 63/67MM DCM MAXIM PS TIBIAL BEARING 10MM X 63/67MM JWH BIOMET 11-146530 492260

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R