BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 36MM RLC LNR +5MM SZ23

    MDR report key: 20521287 · Received October 24, 2024

    Report

    Report Number
    0001825034-2024-02506
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 2, 2024
    Report Date
    February 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    0088030443757
    PMA / PMN Number
    K042051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 650-1057 CER BIOLOXD OPTION HD 36MM LOT 3062925. 650-1068 CER OPTION TYPE 1 TPR SLEVE +6 LOT 3137180. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: G3; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. 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 THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FEMORAL HEAD AND ACETABULAR COMPONENTS WERE REMOVED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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
    2571957 ARCOMXL 36MM RLC LNR +5MM SZ23 PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 65781860 0088030443757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H