BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    MDR report key: 6415365 · Received March 17, 2017

    Report

    Report Number
    3002806535-2017-00152
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 14, 2017
    Report Date
    March 16, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING SECTIONS COULD NOT BE COMPLETED: STERILE DATE - NI. MANUFACTURE DATE - NI. REPORT SOURCE - FOREIGN: EVENT OCCURRED IN (B)(6). PMA 510(K): 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 US MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K911684. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A CLOSED REDUCTION OF HIP PROSTHESIS APPROXIMATELY 15 DAYS POST-IMPLANTATION DUE TO SUBLUXATION. THE PATIENT WAS SUBSEQUENTLY REVISED TWO DAYS LATER DUE TO THE SUBLUXATION. ALL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195213 BIOMET COBALT-CHROME FEMORAL COMPONENTS PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 00J579182

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R PN650-0338 LN3914266 TAPERLOC FEMORAL STEM