BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX56MM

    MDR report key: 7149599 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-11474
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    February 6, 2016
    Report Date
    December 27, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-173662 M2A 38MM MOD HD STD NK LOT 806250; X11-180316 BI-METRIC/X POR NC LAT 16X160 LOT 370020. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. REVIEW OF REVISION NOTES , FOUND THAT THE DIAGNOSIS INCLUDES INFECTED LEFT TOTAL HIP ARTHROPLASTY, ACUTE LEFT LOWER EXTREMITY DEEP VENOUS THROMBOSIS, SEPSIS WITH COAGULASE-NEGATIVE STAPHYLOCOCCUS, CORONARY ARTERY DISEASE, A MYOCARDIAL INFARCTION, GASTRITIS, ANEMIA, CHRONIC PAIN AND MORBID OBESITY IT IS NOTED THAT THERE IS A BLOOD LOSS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. 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 · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, PATIENT REQUIRED A BLOOD TRANSFUSION ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928617 M2A 1 PC SHELL 38MMX56MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 590210

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R