BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR MODULAR HEAD 54MM

    MDR report key: 8138016 · Received December 6, 2018

    Report

    Report Number
    3005975929-2018-00530
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 14, 2006
    Report Date
    February 20, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    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: [212983 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED DUE TO INFECTION OF THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977050 BHR MODULAR HEAD 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R ACETABULAR CUP, # 74120162, LOT # UNKNOWN| FEMORAL STEM, # 71306113/ LOT # UNKNOWN| ACETABULAR CUP, # 74120162, LOT # UNKNOWN| FEMORAL STEM, # 71306113/ LOT # UNKNOWN