BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL NC 9X125MM

    MDR report key: 13283454 · Received January 18, 2022

    Report

    Report Number
    0001825034-2022-00112
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 3, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#010000663 G7 PPS LTD ACET SHELL 52E LOT#7080156, CAT#30103605 G7 VIT E NEUTRAL LNR 36MM E LOT#65256560, CAT#6500660 UNK HEAD LOT#3090611. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: GENERAL WITH SPINAL/EPIDURAL, ANTERIOR APPROACH, LATERAL FEMORAL CORTICAL PERFORATION OCCURRED AND REPAIRED INTRAOPERATIVELY. 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

    IT WAS REPORTED THAT DURING THE LEFT TOTAL HIP ARTHROPLASTY A LATERAL FEMORAL CORTICAL PERFORATION OCCURRED AND REPAIRED INTRAOPERATIVELY. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216014 ECHO POR FMRL NC 9X125MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 735450

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other