BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN VERSYS FULLY POROUS-COATED FEMORAL STEM

    MDR report key: 6603155 · Received May 31, 2017

    Report

    Report Number
    0001822565-2017-03699
    Event Type
    Death
    Date Received
    May 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE ARTICLE WAS ACCEPTED. CONCOMITANT MEDICAL PRODUCTS- UNKNOWN TRILOGY MODULAR TRABECULAR METAL SHELL, UNKNOWN LONGEVITY HIGHLY CROSS-LINKED POLYETHYLENE LINER, UNKNOWN FEMORAL HEAD; THERAPY DATE UNKNOWN ABDEL, M. P., CHALMERS, B. P., TROUSDALE, R. T., HANSSEN, A. D., & PAGNANO, M. W. (2017). RANDOMIZED CLINICAL TRIAL OF 2-INCISION VS MINI-POSTERIOR TOTAL HIP ARTHROPLASTY: DIFFERENCES PERSIST AT 10 YEARS. THE JOURNAL OF ARTHROPLASTY. DOI:10.1016/J.ARTH.2017.04.005 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-03700, 0001822565-2017-03701, 0001822565-2017-03702.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 PATIENTS WHO UNDERWENT TOTAL HIP ARTHROPLASTY EXPIRED PRIOR TO THE 10 YEAR FOLLOW UP. NO FURTHER INFORMATION HAS BEEN PROVIDED AND CAUSES OF DEATHS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384522 UNKNOWN VERSYS FULLY POROUS-COATED FEMORAL STEM PROSTHESIS, HIP KWA ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death