BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP

    MDR report key: 6964332 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-08902
    Event Type
    Death
    Date Received
    October 20, 2017
    Report Date
    October 16, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PUNK
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT-(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. BERNTHAL, N. M., MD, PRICE, S. L., MD, MONUMENT, M. J., MD, WILKINSON, B., BS, JONES, K. B., MD, & RANDALL, R. L., MD. (2015). OUTCOMES OF MODIFIED HARRINGTON RECONSTRUCTIONS FOR NONPRIMARY PERIACETABULAR TUMORS: AN EFFECTIVE AND INEXPENSIVE TECHNIQUE. ANNALS OF SURGICAL ONCOLOGY, 22(12), 3921-3928. DOI:10.1245/S10434-015-4507-2.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "OUTCOMES OF MODIFIED HARRINGTON RECONSTRUCTIONS FOR NONPRIMARY PERIACETABULAR TUMORS: AN EFFECTIVE AND INEXPENSIVE TECHNIQUE". THE JOURNAL ARTICLE REPORTS THAT THERE WERE THIRTY FOUR DEATHS FOR UNKNOWN CAUSE AND UNKNOWN DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744868 UNKNOWN HIP HIP PROSTHESIS LPH ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death