BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FEM RED LAT NC 14X150

    MDR report key: 7391696 · Received April 3, 2018

    Report

    Report Number
    0001825034-2018-02330
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    November 21, 2016
    Report Date
    April 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 640510, 192514 ECHO POR FEM RED LAT NC 14X150 085260, EP-200156 ACT ARTIC E1 HIP BRG 28X50MM S56 DIA28 049150, 650-1055 CER BIOLOXD OPTION HD 28MM 017250, US157856 M2A-MAGNUM PF CUP 56ODX50ID 475950. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NODISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE ROOT CAUSE CAN LIKELY BE ATTRIBUTED TO THE NON COMPATIBILITY OF THE COMPONENTS USED IN THE PROCEDURE,HOWEVER DEFINITIVE 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 · 1

    DURING THE PROCEDURE THERE WAS DIFFICULTY IMPACTING THE ACTIVE ARTICULATION CONSTRUCT ONTO THE STEM TRUNNION. THE CONSTRUCT WAS SEATED INSIDE THE CUP AND THE STEM WAS ALIGNED AND PLACED INSIDE THE TAPER TO COMPLETE THE PROCEDURE. A FORTY-FIVE MINUTE DELAY RESULTED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235046 ECHO POR FEM RED LAT NC 14X150 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 085260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O