BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE TKA GUIDE/MODEL SET 03-05

    MDR report key: 2873399 · Received December 14, 2012

    Report

    Report Number
    0001825034-2012-02598
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 26, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PLANNING AND PROCEDURES DETERMINED THE COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. INVESTIGATION SHOWED THAT THE SEGMENTATION FOR THIS CASE DOES NOT ACCOUNT FOR THE VALGUS CUT EXPERIENCED INTRAOPERATIVELY. INCORRECT PLACEMENT COULD ALSO CAUSE INCORRECT RESECTIONS.

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY UTILIZING A SIGNATURE KNEE GUIDE ON (B)(6) 2012. DURING THE PROCEDURE, THE KNEE WAS CUT TOO MUCH VALGUS CAUSING THE SURGEON TO INTERVENE AND AUGMENT LATERAL IN ORDER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE TKA GUIDE/MODEL SET 03-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 064407

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R