BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG TKA GDE/MDL SET 03-05

    MDR report key: 2901896 · Received January 8, 2013

    Report

    Report Number
    0001825034-2013-00055
    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

    EVALUATION OF PLANNING AND PROCEDURES DETERMINED NO ROOT CAUSE WAS FOUND THROUGHOUT THE PROCESS EXPLAINING THE REPORTED COMPLAINT. THE DEVICE MET SPECIFICATIONS. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE CORRECTED EXPIRATION DATE.

    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 IN THE PROCEDURE OF GREATER THAN 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9874 SIG TKA GDE/MDL SET 03-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 065568

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R