BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD -6MM NK

    MDR report key: 8377966 · Received February 28, 2019

    Report

    Report Number
    0001825034-2019-00879
    Event Type
    Injury
    Date Received
    February 28, 2019
    Date of Event
    April 15, 2004
    Report Date
    February 28, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 10-104062 ¿ M2A TAPER SHELL ¿ 846650; 15-105004 ¿ M2A TAPER LINER ¿ 963340; 162307 ¿ BI-METRIC FEMORAL STEM - 966440; 103536 ¿ LOW PROFILE SCREW ¿ 238880; 103533 ¿ LOW PROFILE SCREW ¿ 000310. 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 - 2019 - 00876, 0001825034 - 2019 - 00877, 0001825034 - 2019 - 00880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED APPROXIMATELY 1000ML OF BLOOD LOSS DURING AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. DURING THE SAME DAY, THE PATIENT UNDERWENT A REVISION SURGERY AND EXPERIENCED ABOUT 500ML OF BLOOD LOSS, FOR A TOTAL OF APPROXIMATELY 1500ML IN ONE DAY. NO MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE. 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
    171168 32MM M2A MOD HEAD -6MM NK PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 335980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization