BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS TIBIAL BEARING 79/83X10

    MDR report key: 3802646 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03801
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 15, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. REVIEW OF POST OP RADIOGRAPHS REVEALED PATIENT RETAINED A FOREIGN BODY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED TO REMOVE THE FOREIGN BODY WHICH APPEARED TO BE METAL FLAKES. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281542 E1 VNGD PS TIBIAL BEARING 79/83X10 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 718180

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R