BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMORIS FEMORAL STEM

    MDR report key: 6911534 · Received October 3, 2017

    Report

    Report Number
    3002806535-2017-00913
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 15, 2017
    Report Date
    October 3, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER K050441. THE INVESTIGATION IS IN PROCESS. 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 PROCEDURE TO REMOVE OSSIFICATION APPROXIMATELY FIVE YEARS POST-TOTAL HIP ARTHROPLASTY. THE HETEROTOPIC OSSIFICATION WAS REPORTED TO BE RELATED TO THE INITIAL PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691977 PRIMORIS FEMORAL STEM PROSTHESIS, HIP JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R UNKNOWN CUP| UNKNOWN HEAD| UNKNOWN LINER