BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B HI 80MM

    MDR report key: 17278133 · Received July 7, 2023

    Report

    Report Number
    0001825034-2023-01495
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 14, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304473935
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01496, 0001825034 - 2023 - 01497. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: PERIPROSTHETIC FRACTURE OF THE RIGHT FEMUR AS NOTED. 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 THERE WAS A PERI-PROSTHETIC FEMUR FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613348 ARCOS CON SZ B HI 80MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 324190 00880304473935

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H