BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM

    MDR report key: 6010441 · Received October 7, 2016

    Report

    Report Number
    0001825034-2016-04009
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    August 20, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. UDI: (B)(4).

    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 DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042757. THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2016-03988 & 04005 & 04009 & 04012).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ENROLLED IN A CLINICAL STUDY AND UNDERWENT A LEFT REVISION PROCEDURE DUE TO DISLOCATION APPROXIMATELY FIVE MONTHS POST-IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ENROLLED IN A CLINICAL STUDY AND EXPERIENCED PAIN AND A CLUNKING FEELING CAUSED BY DISLOCATION. PATIENT UNDERWENT A LEFT REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663292 VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 3621526

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R