BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET

    MDR report key: 7930571 · Received October 3, 2018

    Report

    Report Number
    0002648920-2018-00707
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    August 27, 2018
    Report Date
    October 3, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK960658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.. ROOT CAUSE WAS UNABLE TO 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 00801803202, FEMORAL HEAD, LOT # 63775882, ITEM # 4265, CUP, LOT # 2920056, ITEM # 0100013509, INSERT, LOT # 2920752. THE EVENT OCCURRED IN (B)(6). MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0002648920-2018-00706, 0002648920-2018-00707.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION APPROXIMATELY 5 MONTHS POST IMPLANTATION. PATIENT DEVELOPED A PUSS FILLED WOUND WHILE IN REHAB WARD. THE SURGEON BECAME AWARE OF THE WOUND APPROXIMATELY 3 WEEKS POST OP. A WASH OUT AND DEBRIDEMENT WAS PERFORMED APPROXIMATELY 3 WEEKS POST OP. THE INFECTION WAS NOT RESOLVED, WHICH RESULTED IN A REVISION SURGERY. THE SURGEON EXPLANTED ALL COMPONENTS AND CEMENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770668 FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET HIP PROSTHESIS JDI ZIMMER MANUFACTURING B.V. N/A 63895896

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R