BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 13X170MM

    MDR report key: 8361178 · Received February 22, 2019

    Report

    Report Number
    0001825034-2019-00686
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 15, 2019
    Report Date
    May 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES WHICH INDICATED SURGEON OBSERVED METALLOSIS, STAINING AND DAMAGE OF TISSUE, SYNOVIAL FLUID DARK COLORED, AND CORROSION OF THE FEMORAL NECK JUNCTION. SURGEON ALSO REPORTED EXTENSIVE OSTEOLYSIS OF FEMUR AND BONE LOSS OF THE ACETABULUM. DURING THE ATTEMPT TO REMOVE A WELL FIXED STEM, IT WAS NOTED THE GREATER TROCHANTER FRACTURED ALONG WITH FRAGMENTATION WHILE PERFORMING THE TROCHANTER OSTEOTOMY. THE SURGEON BELIEVE THAT THE FRACTURE WAS DUE TO SIGNIFICANT OSTEOLYSIS AND THINNING OF THE BONE. NEW IMPLANTS WERE INSERTED AND HIP WAS FOUND STABLE. THE IMAGES OF THE STEM, HEAD, METAL LINER, CUP, AND BONE SCREWS WERE PROVIDED. A BLACK RING CAN BE SEEN IN THE TAPER OF THE STEM. BONE RESIDUAL DEBRIS WAS FOUND ON THE POROUS PORTION OF THE STEM. A DARK RED DOT AND RED STAIN WAS OBSERVED ON THE PROXIMAL PORTION LATERAL SIDE OF THE STEM, WHICH COULD POSSIBLY BE BLOOD. OSTEOLYSIS IS LIKELY THE REASON FOR BONE FRACTURE. HOWEVER, REASON FOR OSTEOLYSIS CANNOT BE DETERMINED. THE ROOT CAUSE CANNOT BE DETERMINED. 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

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 15-105000 ¿ LINER ¿ 867990, 15-103662 ¿ SHELL ¿ 012050, 11-163664 ¿ HEAD ¿ 898710, 103532 ¿ SCREW ¿ 078380, 103534 ¿ SCREW ¿ 010770. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT WAS DISCARDED. 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 THAT PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 17 YEARS POST IMPLANTATION DUE TO SEVERE AND EXTENSIVE METALLOSIS. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A GREATER TROCHANTER FRACTURE WHILE THE SURGEON ATTEMPTED TO REMOVE THE STEM. WHEN ADDRESSING THE FRACTURE, FARTHER FRAGMENTATION RESULTED. PATIENT WAS TREATED WITH A FIXATION PLATE AND CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156482 MLRY-HD POR FMRL 13X170MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 284470

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention