BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGRD CR POR/HA FEM - RT 72.5

    MDR report key: 5539614 · Received March 31, 2016

    Report

    Report Number
    3002806535-2016-00166
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 4, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. THE FOLLOWING SECTION COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: IMPLANT DATE - UNKNOWN. THIS PRODUCT IS NOT MANUFACTURED BY ZIMMER BIOMET U.S. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023546. REQUESTED BUT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO INFECTION AND LOOSENING OF THE FEMORAL COMPONENT. A LATERAL DISTAL FEMORAL AUGMENT WAS IMPLANTED DUE TO BONE CAVITATION ON THE LATERAL FEMORAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193561 VANGRD CR POR/HA FEM - RT 72.5 PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 2275584

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R