BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX50MM CUP

    MDR report key: 8063543 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10572
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    December 6, 2016
    Report Date
    November 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO PAIN, TRUNNIONOSIS, ELEVATED METAL ION LEVELS AND METALLOSIS. LAB RESULTS RECEIVED PRIOR TO THE REVISION SURGERY NOTE THAT PATIENT HAS A CHROMIUM LEVEL OF 4.3NG/ML AND A COBALT LEVEL OF 5.8NG/ML. THE SURGEON OPTED TO REPLACE THE HEAD COMPONENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-173665 ¿ M2A HEAD ¿ 669200; X180311 ¿ BI-METRIC STEM ¿ 885140; 120010 ¿ COCR CABLE/SLEEVE - 955810. CUSTOMER HAS INDICATED THAT 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 - 2018 - 10570; 0001825034 - 2018 - 10571.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. 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
    903462 M2A 38MMX50MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 429070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R