BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMHR MODULAR HEAD 54MM

    MDR report key: 8156026 · Received December 12, 2018

    Report

    Report Number
    3005975929-2018-00535
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    August 8, 2018
    Report Date
    July 4, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [223350 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WALKED, FELL OVER AND BROKE THE FEMORAL NECK. A REVISION IS REQUIRED. THE DEVICE WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997034 BMHR MODULAR HEAD 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R BHR ACECTABULAR CUP 62, # 74120162, LOT # UNKNOWN| BMHR MODULAR STEM, # 74431314, LOT # UNKNOWN| UNKNOWN BHR DEVICE/ UNKNOWN LOT| UNKNOWN BHR DEVICE/ UNKNOWN LOT