BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ B HI 60MM TRL

    MDR report key: 19529201 · Received June 13, 2024

    Report

    Report Number
    0001825034-2024-01583
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 23, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H3, H6 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 31-301852 ARCOS 3.5MM HEX DRIVE ZB160103. 31-301852 ARCOS 3.5MM HEX DRIVE Z1812492. UNKNOWN STEM UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROXIMAL TRIAL BODY STUCK ON THE STEM AND THE SCREW STRIPPED. THE TECHNIQUE IS TO IMPLANT THE STEM AND TRIAL WITH THE BODY OF THE REAL STEM BEFORE DECIDING ON THE REAL BODY AND VERSION. SURGERY WAS NOT A REVISION OF ZIMMER BIOMET PRODUCTS, AND THE STEM WAS IMPLANTED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795476 ARCOS CON SZ B HI 60MM TRL HIPS, INSTRUMENTS KWA ZIMMER BIOMET, INC. N/A 675190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.