BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES A PAT W/WR STD 34 1 PEG

    MDR report key: 3182929 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02136
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02134 / 02137). REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO INFECTION. COMPONENTS WERE REMOVED AND REPLACED WITH STAGE ONE SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282971 SERIES A PAT W/WR STD 34 1 PEG PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 761850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R