BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL LAT NC

    MDR report key: 10801084 · Received November 6, 2020

    Report

    Report Number
    0001825034-2020-04012
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    September 22, 2020
    Report Date
    January 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K070274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED BY THE REVIEW OF MEDICAL RECORDS/RADIOGRAPHS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SMALL NON-DISPLACED CRACK/FRACTURE IN THE MEDIAL CALCAR OF PROXIMAL FEMUR, MEDICAL INTERVENTION/MODIFICATION ¿ PROBABLY NWB PWB, OR TTWB, ISSUE HAS BEEN RESOLVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UDI #: (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM# 010000663/ G7 SHELL/ LOT # 6793496; ITEM# 30113605/ G7 LINER/ LOT # 64658201; ITEM# 650-0661/ DELTA HEAD/ LOT # 3033054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, ON THE SAME DAY, IT WAS NOTED THE PATIENT HAD A SMALL NON-DISPLACED CRACK/FRACTURE IN THE MEDIAL CALCAR OF PROXIMAL FEMUR. IT WAS RESOLVED ONE-MONTH POST-SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269331 ECHO POR FMRL LAT NC PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. NI 657970

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other