BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR TIBIAL LOCKING BAR

    MDR report key: 6308979 · Received February 7, 2017

    Report

    Report Number
    0001825034-2017-00522
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    January 5, 2017
    Report Date
    June 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK063732
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW CATALOG 141314 LOT 304970; REGENEREX BIOMET PRIMARY TIBIAL TRAY 75MM WITH LOCKING BAR CATALOG 141274 LOT 295310; VANGAURD KNEE SYSTEM CR FEMORAL ¿ LEFT 67.5MM CATALOG 183070 LOT 800010; VANGUARD KNEE SYSTEM AS TIBIAL BEARING 10MM 75MM CATALOG 189080 LOT 553000. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00517 / 1825034-2017-00522).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A TOTAL KNEE REVISION DUE TO CONTINUED PAIN AND STIFFNESS 17 DAYS POST BEARING EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89565 BIOMET MODULAR TIBIAL LOCKING BAR PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 125220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R