BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW

    MDR report key: 6308986 · Received February 7, 2017

    Report

    Report Number
    0001825034-2017-00518
    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
    PK915132
    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. (B)(4). CONCOMITANT MEDICAL PRODUCTS - REGENEREX BIOMET PRIMARY TIBIAL TRAY 75 MM WITH LOCKING BAR, CATALOG :141274, LOT: 295310; VANGUARD KNEE SYSTEM CR FEMORAL ¿ LEFT 67.5 MM, CATALOG: 183070, LOT: 800010; VANGUARD KNEE SYSTEM AS TIBIAL BEARING 10MM 75 MM, CATALOG: 189080, LOT: 553000; BIOMET MODULAR TIBIAL LOCKING BAR, CATALOG: 141205, LOT: 125220. THIS REPORT IS NUMBER 2 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
    89681 BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 304970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R