BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 7633421 · Received June 25, 2018

    Report

    Report Number
    0001825034-2018-04001
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    December 30, 2015
    Report Date
    June 27, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 15-106056, M2A-38 CUP NON FLARED SZ 56MM, 952330; 103207, TAPERLOC POR FMRL 13.5X147, 109310. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04000, 0001825034 - 2018 - 04002. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES WHICH CONFIRMED THE PATIENT'S BLOOD LOSS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLOOD LOSS OF 800 CC REQUIRING A TRANSFUSION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477644 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 603760 

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R