BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL/X POR RED PROX 13MM

    MDR report key: 8804668 · Received July 18, 2019

    Report

    Report Number
    0001825034-2019-03086
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 5, 2018
    Report Date
    July 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K042029
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TRI-SPIKE SHELL W/APEX HL 54MM, # ITEM 101005, LOT: 644750; E-POLY 40MM +3 HIWALL LNR SZ24, # ITEM EP-108524, LOT: 376410; SELEX/MAGNUM MOD HD 40MM +3, # ITEM S331140, LOT: 902420. 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, 0001825034-2019-09839.

    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. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598026 INTEGRAL/X POR RED PROX 13MM PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 205690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R