BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 14X79/83MM

    MDR report key: 4222216 · Received November 3, 2014

    Report

    Report Number
    0001825034-2014-08482
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 24, 2014
    Report Date
    February 4, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A MEDIAL RETINACULUM REPAIR PROCEDURE ON (B)(6) 2014 DUE TO A MEDIAL RETINACULUM TEAR AFTER A PATIENT FALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT HAD A FALL AND EXPERIENCED AN UNKNOWN ADVERSE EVENT ON (B)(6) 2014. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702283 VNGD PS TIB BRG 14X79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 742690

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R