BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ E HI 60MM

    MDR report key: 10417133 · Received August 17, 2020

    Report

    Report Number
    0001825034-2020-03207
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304480551
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED THAT THE CARTON AND STERILE PACKAGING WAS DAMAGED. THE STERILITY OF THE PRODUCT IS COMPROMISED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET CONTROL WAS CONFORMING TO SPECIFICATIONS. THE ROOT CAUSE IS ATTRIBUTED TO TRANSIT DAMAGE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED WITH PACKAGING DAMAGE AND THE STERILITY BARRIER POTENTIALLY COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877002 ARCOS CON SZ E HI 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 714460 00880304480551

    Patients

    Seq Age Sex Outcome Treatment
    1