BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SEGMENTAL ANCHOR PLUG

    MDR report key: 1051599 · Received May 21, 2008

    Report

    Report Number
    1825034-2008-00157
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K043547
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATES THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. THE FOLLOWING USER FACILITY INFO IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL KNEE ARTHROPLASTY IN LATE 2007. PT COMPLAINED OF LEG PAIN AFTER CHEMO-THERAPY TREATMENT IN 2008. RADIOGRAPHS WERE TAKEN AND WERE UNREMARKABLE. SUBSEQUENTLY, PT WAS NON-WEIGHT BEARING AND RADIOGRAPHS INDICATED PROSTHESIS HAD FRACTURED. REVISION PROCEDURE WAS PERFORMED ON THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESS SEGMENTAL ANCHOR PLUG KWA BIOMET, INC. NA 054920

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R