BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG TKA GDE/MDL SET 04-05

    MDR report key: 2840685 · Received November 20, 2012

    Report

    Report Number
    0001825034-2012-02462
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE REPORTED ISSUE WAS LIMITED TO PLANNING AND PROCEDURES AS NO PRODUCT WAS RETURNED. SUPPLIER REVIEW OF PLANNING AND PROCEDURES FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. THE PATIENT HAD A VALGUS KNEE OF ABOUT 15 DEGREES AND UPON CUTTING THE TIBIAL IT APPEARED THE TIBIAL SIGNATURE GUIDE MADE CUTS FOR A VARUS KNEE. TRADITIONAL INSTRUMENTATION WAS USED TO FINISH THE PROCEDURE, HOWEVER THE EVENT CAUSED A DELAY OF OVER THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG TKA GDE/MDL SET 04-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 062494

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R