BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX54MM CUP

    MDR report key: 11894127 · Received May 27, 2021

    Report

    Report Number
    0001825034-2021-01642
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    February 6, 2014
    Report Date
    June 24, 2021
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF LEGAL DOCUMENTS RECEIVED. MEDICAL RECORDS INDICATE THE INITIAL PROCEDURE WAS COMPLETED IN 2003, WITH REVISIONS IN 2012, 2014, 2019. OPERATIVE NOTES WERE NOT PROVIDED FOR THE 2014 OR PRIOR REVISIONS, HOWEVER, THE EVENTS ARE DOCUMENTED IN THE LEGAL DOCUMENT. THE DEVICE HISTORY RECORD (DHR) 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 REPORT 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). CONCOMITANT MEDICAL DEVICES: 11-173660 880880 M2A 38MM MOD HD -6MM NK; 11-103205 LOT 477450 TAPERLOC FEMUR. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REMAINS IMPLANTED. 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: 1825034-2014-01377.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, LACK OF MOBILITY, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND ELEVATED METAL ION LEVELS. THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794291 M2A 38MMX54MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 708690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE