BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET INTERLOK 79MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

    MDR report key: 6136937 · Received November 30, 2016

    Report

    Report Number
    0001825034-2016-04795
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    August 4, 2015
    Report Date
    May 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    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 5 OF 8 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04791 / 04798).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT EXPIRED 19 DAYS POST KNEE ARTHROPLASTY DUE TO ALLEGED SEVERE INJURIES, INCLUDING INFECTION, SUSTAINED FROM EXTENSIVE SURGICAL INTERVENTION AND EXTENSIVE MEDICAL TREATMENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786576 BIOMET INTERLOK 79MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A J3549652

    Patients

    Seq Age Sex Outcome Treatment
    1 Death