BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 70MM

    MDR report key: 7938160 · Received October 5, 2018

    Report

    Report Number
    0001825034-2018-09357
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    October 3, 2005
    Report Date
    January 4, 2019
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). WEIGHT IS UNKNOWN, OPERATIVE REPORT STATES HE IS SIGNIFICANTLY OVERWEIGHT. CONCOMITANT MEDICAL PRODUCTS: 11-173665 ¿ M2A MODULAR HEAD ¿ 028140, X11-180315 ¿ BI-METRIC STEM ¿ 450570. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09356, 0001825034-2018-09358.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT HIP PROCEDURE, PATIENT EXPERIENCED 900CC OF BLOOD LOSS AND RECEIVED 2 UNITS OF PACKED BLOOD CELLS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779368 M2A-38 CUP NON FLARED SZ 70MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 912330

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O