BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PATELLA COMPONENTS

    MDR report key: 6428661 · Received March 23, 2017

    Report

    Report Number
    0001825034-2017-01985
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    December 19, 2016
    Report Date
    April 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE EXPLANTED ¿ NI. CONCOMITANT MEDICAL PRODUCTS: VNGD PAT-SPEC CR FMRL 62.5 RT PART NUMBER: 181906 LOT NUMBER: 984390, BIOMET COCR FINNED TIB TRAY 67 MM PART NUMBER: 141232 LOT NUMBER: J3841836, E1 VNGD AS TIB BRG 11X67 PART NUMBER: EP-189041 LOT NUMBER: 008610. THIS COMPLAINT WAS INITIALLY REPORTED UNDER THE INCORRECT MFR NUMBER: 0001822565-2017-01438. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01977, 0001825034-2017-01978, MDT65199 0001825034-2017-01981, MDT65209 0001825034-2017-01985.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, ON (B)(6) 2016 IT WAS REPORTED THAT THE PATIENT SUFFERED MEDIAL RETINACULAR TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211211 VANGUARD PATELLA COMPONENTS PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 478710

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R