BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PS DCM TIB BRNG 22X63/67MM

    MDR report key: 3123541 · Received May 22, 2013

    Report

    Report Number
    0001825034-2013-01603
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY IN 1999. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013, DUE TO THE TIBIA HAD INTERNALLY ROTATED DURING THE INITIAL PROCEDURE. THE TIBIA BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225840 MAX PS DCM TIB BRNG 22X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 776390

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R