BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 56MM

    MDR report key: 7538544 · Received May 23, 2018

    Report

    Report Number
    0001825034-2018-03525
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    June 30, 2014
    Report Date
    May 22, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 11-173662 M2A 38MM MOD HD STD NK 414290; X11-180311 BI-METRIC/X POR NC LAT 11X135 810820. THE COMPLAINT WAS CONFIRMED BASED ON THE SURGICAL OP NOTES THAT WERE PROVIDED. NO COMPLICATIONS WERE NOTED DURING THE SURGERY. THE COMPLAINT SAMPLES WERE NOT RETURNED BASED ON THE HOSPITAL POLICY. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT CONTRIBUTE TO THE REPORTED EVENT. A ROOT CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03526.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT SUFFERED BLOOD LOSS OF 1300 ML DURING REVISION OF RIGHT TOTAL HIP ARTHROPLASTY. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381172 M2A-38 CUP NON FLARED SZ 56MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 087070

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other