BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO B-MTRC MP FP SO 8

    MDR report key: 7513282 · Received May 14, 2018

    Report

    Report Number
    0001825034-2018-02958
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    March 16, 2018
    Report Date
    April 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK143009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 12115115, FEMORAL HEAD, 2898666; 010000662, G7 PPS LTD ACET SHELL 50D, 6161065; 010000848, G7 NEUTRAL E1 LINER 32MM D, 6152297. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE REAL STEM SUBSIDED RELATIVE TO THE BROACH. THERE WAS CONCERN ABOUT AN UNRECOGNIZED FRACTURE, SO TWO CABLES WERE PLACED TO RETAIN THE STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355317 ECHO B-MTRC MP FP SO 8 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 613360

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R