BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14

    MDR report key: 5643671 · Received May 10, 2016

    Report

    Report Number
    3006946279-2016-00069
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    April 6, 2016
    Report Date
    April 12, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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 K911684. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00069 / 3002806535-2016-00232).

    Description of Event or Problem · 1

    PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO DISLOCATION OF THE FEMORAL HEAD. THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299400 COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14 PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. N/A 00J3617033

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R