BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP 56MM

    MDR report key: 8392047 · Received March 5, 2019

    Report

    Report Number
    3005975929-2019-00113
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    November 7, 2017
    Report Date
    September 11, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT CORRECTED.SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. 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, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [236691 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183804 BHR ACETABULAR CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    0 Hospitalization| R
    1 67 YR Hospitalization| H| R| R FEMORAL STEM, # 71309116, LOT # UNKNOWN| HEMI HEAD, # 74122550, LOT # UNKNOWN| MODULAR SLEEVE, # 74222100, LOT # UNKNOWN| UNKNOWN BHR MODULAR FEMORAL HEAD| UNKNOWN SYNERGY STEM| UNKNOWN BHR MODULAR FEMORAL HEAD| UNKNOWN SYNERGY STEM