BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ C HI 80MM

    MDR report key: 18561995 · Received January 23, 2024

    Report

    Report Number
    0001825034-2024-00124
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    December 29, 2023
    Report Date
    April 4, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304474635
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 650-1068 LOT# 3049620 CER OPTION TYPE 1 TPR SLEVE +6. CAT# 650-1055 LOT# 3123214 CER BIOLOXD OPTION HD 28MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2024 - 00123. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: G3; H2; H3: H6. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM COMPLAINT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. 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 THE PATIENT WAS REVISED APPROXIMATELY ONE DAY POST IMPLANTATION BECAUSE IT WAS DISCOVERED THE STEM AND BODY WERE NOT PROPERLY SEATED IN A POST-OP X-RAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825970 ARCOS CON SZ C HI 80MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 250900 00880304474635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H10 NARRATIVE