BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HEAD

    MDR report key: 7999713 · Received October 24, 2018

    Report

    Report Number
    0001825034-2018-09839
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    June 5, 2018
    Report Date
    July 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K062997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : TRI-SPIKE SHELL W/APEX HL 54MM # ITEM 101005 LOT 644750 , INTEGRAL/X POR RED PROX 13MM # ITEM X12-171313 LOT 205690 , SELEX/MAGNUM MOD HD 40MM +3 # ITEM S331140 LOT 902420 (LOT CORRECTED). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09837, 0001825034-2019-03086.

    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 PRODUCTS: TRI-SPIKE SHELL W/APEX HL 54MM # ITEM 101005 LOT 644750 , INTEGRAL/X POR RED PROX 13MM # ITEM X12-171313 LOT 205690, E-POLY 40MM +3 HIWALL LNR SZ24 # ITEM EP-108524 LOT 376410. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09839. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST INITIAL HIP SURGERY DUE TO PAIN, FEELING DIZZY, AND DISLOCATION. THE PATIENT ALLEGES METALLOSIS, SEVERE NERVE DAMAGE TO THE MUSCLES AND TISSUES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842869 SELEX/MAGNUM MOD HEAD PROSTHESIS HIP LZO ZIMMER BIOMET, INC. N/A 902420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R