BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL CENTRALIZER FEMORAL

    MDR report key: 6594908 · Received May 26, 2017

    Report

    Report Number
    0001825034-2017-03422
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    February 16, 2017
    Report Date
    June 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDG
    PMA / PMN Number
    PK942479
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT PRODUCTS: PART: 12-139012 NAME: ENDO II MOD LOT: 730590 PART: 162656 NAME: INGL ANSR OMPCT DSTL PSNTR LOT: 528330 PART: 139247 NAME: ENDO II TAPER INSERT LOT: 607230. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PRODUCT NUMBER AND THE LOT NUMBER WERE NOT PROVIDED; THEREFORE, THE MANUFACTURING DATE, THE DEVICE HISTORY RECORDS AND THE FIELD AGE OF THE DEVICE COULD NOT BE DETERMINED. THERE IS INSUFFICIENT INFORMATION TO PERFORM A COMPLAINT HISTORY SEARCH. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS DEVICE WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375175 INTEGRAL CENTRALIZER FEMORAL PROSTHESIS, HIP JDG BIOMET ORTHOPEDICS N/A 204490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R