BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR POROUS/HA FEM - RT 72.5

    MDR report key: 5521069 · Received March 23, 2016

    Report

    Report Number
    3002806535-2016-00130
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    February 9, 2016
    Report Date
    February 26, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER LATE POSTOPERATIVE COMPLICATIONS, NUMBER 7 STATES, "ALLERGIC REACTION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO ALLEGDED NICKEL ALLERGY. THE FEMORAL IMPLANT AND POLYETHYLENE TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175994 VANGUARD CR POROUS/HA FEM - RT 72.5 PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 2446580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R