BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FEM RED LAT

    MDR report key: 12669445 · Received October 20, 2021

    Report

    Report Number
    0001825034-2021-02871
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    January 3, 2017
    Report Date
    January 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONE ECHO POR FEM RED LAT NC 12X140 ITEM# 192512 LOT# 992360 APPROXIMATE AGE OF 10 YEARS WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE STEM TAPER HAD FRACTURED AND COULD NOT BE REMOVED FROM THE HEAD. THE STEM SHOWS GOUGING ON THE SHAFT AND FLAT. FRACTURE ARTIFACTS SUGGEST A FATIGUE FAILURE INITIATING ON THE SUPERIOR SIDE OF THE STEM; HOWEVER, THERE ARE INSUFFICIENT IS CERNABLE ARTIFACTS TO CONFIRM THE FAILURE MODE. SEM FOUND FATIGUE STRIATIONS AND DUCTILE DIMPLES, CONFIRMING A FATIGUE FAILURE CULMINATING IN OVERLOAD. XRF ANALYSIS FOUND THE STEM MATERIAL TO BE CONSISTENT WITH TI6-4 TITANIUM ALLOY. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES ADHERENT SUBCUTANEOUS TISSUE OVER GREATER TROCHANTER WAS EXCISED, STEM FRACTURE AT THE TAPER AS REPORTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO THE STEM FRACTURING. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561568 ECHO POR FEM RED LAT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 992360

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R