BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE KNEE GUIDE

    MDR report key: 2160338 · Received July 13, 2011

    Report

    Report Number
    1825034-2011-00562
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. REVIEW OF RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. SUPPLIER'S EVALUATION OF EVENT WAS LIMITED TO REVIEW OF PLANNING AND PROCEDURES AS THE DEVICE HAS NOT BEEN RETURNED TO DATE. SUPPLIER CONFIRMED THAT SURGEON APPROVED PLAN THAT WAS USED TO MANUFACTURE THE GUIDES. GUIDES WERE MANUFACTURED ACCORDING TO PLAN AND MET SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING SIGNATURE KNEE GUIDES ON (B)(6) 2011. DIFFICULTY WITH FEMORAL ROTATION RESULTED IN A DELAY GREATER THAN THIRTY MINUTES. EVENT IS BEING REPORTED AS A DELAY IN THE PROCEDURE WAS INDICATED; NO PRODUCT NON-CONFORMANCES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE KNEE GUIDE GUIDE, KNEE PROSTHESIS JWH BIOMET ORTHOPEDICS N/A 032701

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R