BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX48MM CUP

    MDR report key: 9670608 · Received February 5, 2020

    Report

    Report Number
    0001822565-2020-00485
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 6, 2020
    Report Date
    May 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034 - 2020 - 01996

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: M2A MODULAR HEAD COMPONENT 38 11-173660 LOT# 760670. MALLORY HEAD PRESS FIT FEMORAL11-104107 LOT #28536.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034 - 2020 - 01996

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE SEVENTEEN YEARS LATER DUE TO METALLOSIS, SWELLLING, ELEVATED METAL IONS, NECROSIS AND PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN UNKNOWN HEAD LOT #: UNKNOWN. ITEM #: UNKNOWN UNKNOWN LINER LOT #: UNKNOWN. ITEM #: UNKNOWN UNKNOWN STEM LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001822565 - 2020 - 00497 HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED SEVENTEEN YEARS LATER DUE TO METALLOSIS AND PAIN. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134872 M2A 38MMX48MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 694600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R