BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE KNEE GUIDES 04-05

    MDR report key: 2882215 · Received December 20, 2012

    Report

    Report Number
    0001825034-2012-02613
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK102795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PLANNING AND PROCEDURES DETERMINED THE ROOT CAUSE FOR THE COMPLAINT WAS AN UNDER-SEGMENTATION OF THE GUIDE FIT REGION OF THE TIBIA.

    Additional Manufacturer Narrative · 1

    EVALUATION OF PLANNING AND PROCEDURES IS IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY UTILIZING SIGNATURE KNEE GUIDES ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO THE SLOPE WAS INVERSED A FEW DEGREES IN THE TIBIAL CUT. THE SURGEON DID A MANUAL RECUT AND REMOVED THE TIBIA AND REPLACED WITH A CEMENTED TIBIA WITH A KEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE KNEE GUIDES 04-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 035919

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R