BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG DA360 TIB BRG ARCM 71/75X24

    MDR report key: 5774916 · Received July 7, 2016

    Report

    Report Number
    0001825034-2016-02482
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    April 6, 2016
    Report Date
    June 8, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    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

    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 COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF BIRTH - (B)(6). 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 K093293. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-02482 & 02479). REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT MANIPULATION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO DIFFICULTY IN OBTAINING FULL EXTENSION OF KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429018 VG DA360 TIB BRG ARCM 71/75X24 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2684679

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R