BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PS DCM TIB BRNG 10X63/67MM

    MDR report key: 3895244 · Received June 25, 2014

    Report

    Report Number
    0001825034-2014-05419
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2000. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2000. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371105 MAX PS DCM TIB BRNG 10X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 462950

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R