BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC TIB BRG 18X71/75

    MDR report key: 5745882 · Received June 23, 2016

    Report

    Report Number
    0001825034-2016-02244
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    June 21, 2012
    Report Date
    March 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02244 / 02245).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: BONE CEMENT - CATALOGUE: 402283, LOT: 892530. PATELLA - CATALOGUE: 11-150842, LOT: 938510. STEM - CATALOGUE: 141622, LOT: 108030. FEMORAL AUGMENT - CATALOGUE: 184246, LOT: 809500. FEMUR - CATALOGUE: 183326, LOT: 599600. TIBIAL STEM - CATALOGUE: 141514, LOT: 187010. FEMORAL AUGMENT - CATALOGUE: 184146, LOT: 150550. STEM - CATALOGUE: 141618, LOT: 346100. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 2 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398797 VNGD SSK PSC TIB BRG 18X71/75 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 476740

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R