BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 7068140 · Received November 29, 2017

    Report

    Report Number
    0001825034-2017-10509
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 23, 2016
    Report Date
    December 8, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK833175
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - PART: US157854 NAME: M2A-MAGNUM PF CUP 54ODX48ID LOT: 941170. COMPLAINT WAS CONFIRMED BASED ON MEDICAL RECORDS. NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE DEVICE IS UNKNOWN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE INFORMATION PROVIDED WAS LIMITED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: UNKNOWN, UNKNOWN M2A CUP, UNKNOWN. CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2017 - 10510.

    Description of Event or Problem · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY DUE TO INCREASING HIP GROIN PAIN. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL IMPLANTATION DUE TO PAIN AND METALLOSIS. THE SURGEON ALSO NOTED THAT THE PAIN MAY BE RELATED TO SYNOVITIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. THE LEGAL COUNSEL FURTHER REPORTS THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATIENT ALLEGATIONS OF PAIN AND METALLOSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848419 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 919170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R