BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 6191361 · Received December 20, 2016

    Report

    Report Number
    0001825034-2016-05301
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 21, 2016
    Report Date
    April 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2016-05291, 0001825034-2016-05291 AND 0001825034-2016-05301).

    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
    839125 CER OPTION TYPE 1 TPR SLEVE -3 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 640510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O