BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR CABLE/SLEEVE SET 2.0MM

    MDR report key: 7112931 · Received December 13, 2017

    Report

    Report Number
    0001825034-2017-11143
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    April 25, 2016
    Report Date
    December 13, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDQ
    PMA / PMN Number
    PK982545
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL 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. 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 WERE FOUND. 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 NINE YEARS POST-IMPLANTATION DUE TO PAIN AND DIFFICULTY WALKING AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895268 COCR CABLE/SLEEVE SET 2.0MM HIP PROSTHESIS JDQ ZIMMER BIOMET, INC. N/A 512780

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R