BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B STD 60MM

    MDR report key: 19671642 · Received July 3, 2024

    Report

    Report Number
    0001825034-2024-01766
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 13, 2024
    Report Date
    October 3, 2024
    Manufacturer
    .
    Product Code
    KWA
    UDI-DI
    00880304474123
    PMA / PMN Number
    K090757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. 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. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. RADIOGRAPH WAS PROVIDED, HOWEVER COULD NOT BE REVIEWED BY A HEALTH CARE PROFESSIONAL AS THE IMAGES WERE NOT DATED AND UNABLE TO CORRELATE WITH THE REPORTED EVENT. 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). CONCOMITANT MEDICAL PRODUCTS: 11-301014 ARCOS STS DIST STEM 14X250MM 331030. FOREIGN: AUSTRALIA . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TWO MONTHS POST IMPLANTATION DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281991 ARCOS CON SZ B STD 60MM PROSTHESIS, HIPS KWA . N/A 66055070 00880304474123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE