BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE KNEE GUIDES 03-05

    MDR report key: 2840780 · Received November 20, 2012

    Report

    Report Number
    0001825034-2012-02469
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    July 6, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK102795
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. DEVICE WAS FORWARDED TO SUPPLIER MANUFACTURER FOR EVALUATION. SUPPLIER MANUFACTURER EVALUATION INCLUDED A REVIEW OF PLANNING AND PROCEDURES. UNDERSEGMENTATION OF THE ANTERIOR AND DISTAL CARTILAGE HAVE CAUSED THE ISSUE WITH THE FIT OF THE FEMORAL GUIDE. UNDERSEGMENTATION OF THE LATERAL PLATEAU AND ANTERIOR CORTICAL REGION LIKELY CAUSED THE ISSUE WITH TIBIAL GUIDE FITTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY PROCEDURE UTILIZING SIGNATURE GUIDES ON (B)(6) 2012. DURING THE PROCEDURE, THE FEMORAL AND TIBIAL GUIDES DID NOT FIT WELL ON THE PATIENT'S BONES. THE PROCEDURE WAS COMPLETED USING TRADITIONAL INSTRUMENTATION AND BY IMPLANTING A SMALLER FEMORAL COMPONENT THAN WAS ORIGINALLY PLANNED. THERE WAS NO INJURY TO THE PATIENT OR DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE KNEE GUIDES 03-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 053501

    Patients

    Seq Age Sex Outcome Treatment
    1