BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM

    MDR report key: 6216089 · Received December 30, 2016

    Report

    Report Number
    0001822565-2016-04862
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 28, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    LWJ
    PMA / PMN Number
    PK992667
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - UNKNOWN ZMR CONE BODY, UNKNOWN FEMORAL HEAD, UNKNOWN ACETABULAR COMPONENT. REPORTED EVENT WAS CONFIRMED THROUGH PHOTOS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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 · 1

    PATIENT'S HIP WAS REVISED APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO FRACTURED STEM. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865052 ZMR HIP SYSTEM PROSTHESIS, HIP LWJ ZIMMER, INC. N/A 62042053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R