BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL

    MDR report key: 10163476 · Received June 17, 2020

    Report

    Report Number
    0001825034-2020-02381
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    October 30, 2009
    Report Date
    September 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  THE FOLLOWING SECTIONS WERE  UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:14-380353, LOT NUMBER:198770, BRAND NAME: MONM M2A38 HD. CATALOG NUMBER:7100100306, LOT NUMBER: 2008090173, BRAND NAME: PPF LTZ STEM SZ 06X160MM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034-2020-02380. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN APPROXIMATELY 4 YEARS POST IMPLANTATION BUT REFUSED THE PROPOSED REVISION SURGERY. THE PATIENT UNDERWENT BLOOD TESTS APPROXIMATELY 9 YEARS POST IMPLANTATION WHICH RESULTED IN ELEVATED METAL ION LEVEL. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627746 M2A 1 PC SHELL PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 529970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other