BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 15X155

    MDR report key: 6897868 · Received September 27, 2017

    Report

    Report Number
    0001825034-2017-07356
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    April 25, 2016
    Report Date
    September 27, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    PK020580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03250, 0001825034-2017-03252, 0001825034-2017-03253, 0001825034-2017-07356. CONCOMITANT PRODUCTS: M2A-MAGNUM MOD HD SZ 48MM CATALOG# 157448 LOT# 463020. M2A-MAGNUM 42-50M TPR INSRT +3 CATALOG# 139258 LOT# 958730. M2A-MAGNUM PF CUP 54ODX48ID CATALOG# US157854 LOT# 497650. BI-METRIC/X POR NC 15X155 CATALOG# X180315 LOT# 821410. COCR CABLE/SLEEVE SET 2.0MM CATALOG# 120010 LOT# 512780. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. REVISION OP NOTES INDICATE THAT THE PATIENT UNDERWENT A LEFT THA REVISION DUE OSTEOLYSIS WITH PAIN. TURBID SYNOVIAL FLUID, SOFT TISSUE METALLOSIS, OSTEOLYSIS, AS WELL AS TROCHANTERIC FRACTURE AND BONE EROSION SECONDARY TO OSTEOLYSIS WERE IDENTIFIED INTER-OPERATIVELY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    IT WAS REPORTED BY PATIENTS LEGAL COUNSEL THAT THE PATIENT'S LEFT HIP WAS REVISED EIGHT YEARS POST-IMPLANTATION DUE TO PAIN AND DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678196 BI-METRIC/X POR NC 15X155 HIP, PROSTHESIS MEH ZIMMER BIOMET, INC. 821410

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R