BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FEM RED LAT NC

    MDR report key: 11627304 · Received April 7, 2021

    Report

    Report Number
    0001825034-2021-01010
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 4, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS. VISUAL EXAMINATION OF THE RETURNED PROVIDED PICTURES IDENTIFIED THE STEM IS FRACTURED AS REPORTED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT TOTAL HIP ARTHROPLASTY WITH FRACTURE FEMORAL NECK. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: CAT# 650-1057 DELTA CERAMIC OPTION HEAD DIA3 6 LOT# 3043533; CAT# 650-1066 OPTION TAPER SLEEVE TI 0MM TYP E 1 LOT# 3031079. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 PROCEDURE AT AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO A BREAKAGE OF THE NECK ON THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528427 ECHO POR FEM RED LAT NC PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 889280

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R SEE H10 NARRATIVE.