BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A HI CARBON HEAD

    MDR report key: 7577812 · Received June 7, 2018

    Report

    Report Number
    0001825034-2018-03809
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    April 24, 2018
    Report Date
    December 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: UNKNOWN; ITEM NAME: UNKNOWN STEM; LOT# UNKNOWN. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE CARBON HEAD SHOWS SCUFFING FROM USE AND BLACK DEBRIS INSIDE OF THE TAPER. THE DARK DEBRIS AND DISCOLORATION INSIDE THE TAPER IS CONSISTENT OF BIOLOGICAL MATERIAL, TITANIUM ALLOY, WHICH POSSIBLY TRANSFERRED FROM THE STEM TAPER, AND ELEVATED LEVELS OF CR, MO AND O (POSSIBLY OXIDIZED TAPER CORROSION PRODUCTS). DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CUSTOMER HAS INDICATED THAT THE 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. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 10-104048, ITEM NAME: M2A SHELL, LOT #: 224330, ITEM NUMBER: 15-105011, ITEM NAME: M2A LINER, LOT #: UNKNOWN, ITEM NUMBER: 103531, ITEM NAME: LOW PROFILE SCREW, LOT #: 621040, ITEM NUMBER: 103531, ITEM NAME: LOW PROFILE SCREW, LOT #: 913230. FOREIGN REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03810.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION DUE TO PRESENCE OF A PSEUDOTUMOR. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419632 M2A HI CARBON HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 902310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R