BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG TKA GDE/MDL SET 03-05

    MDR report key: 2901897 · Received January 8, 2013

    Report

    Report Number
    0001825034-2013-00052
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 14, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    SUPPLIER REVIEW OF PLANNING AND PROCEDURES FOUND THE DEVICE DID NOT MEET SPECIFICATION. THE DHR WAS EXAMINED AND THE SEGMENTATION INACCURACIES FOR BOTH THE FEMUR AND TIBIA, ARE CONSIDERED TO HAVE CONTRIBUTED TO THE COMPLAINT REPORT. LOT IS LIMITED TO ONE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGNATURE TOTAL KNEE ARTHROPLASTY, THE GUIDES DID NOT FIT THE PATIENT. VANGUARD PREMIER INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9857 SIG TKA GDE/MDL SET 03-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 064150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R