BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 M2A-38 MOD HD+3.5MM NK 12/14

    MDR report key: 10163471 · Received June 17, 2020

    Report

    Report Number
    0001825034-2020-02380
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    October 30, 2009
    Report Date
    August 12, 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, H10.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). SOURCE: ITALY CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:15-105052 LOT NUMBER: 529970 BRAND NAME: M2A 1 PC SHELL 38MMX52MM, 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 0001825034-2020-02381. 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
    627498 12/14 M2A-38 MOD HD+3.5MM NK 12/14 PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 178770

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10 NARRATIVE