BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRMINGHAM HIP RESURFACING

    MDR report key: 7998921 · Received October 24, 2018

    Report

    Report Number
    3005975929-2018-00387
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 4, 2018
    Report Date
    April 24, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: [212558 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INCREASED SYMPTOMS AND INCREASINGLY LARGE CYST FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841464 BIRMINGHAM HIP RESURFACING RESURFACING FEMORAL HEAD 50MM NXT SMITH & NEPHEW ORTHOPAEDICS LTD 78331

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R ACETABULAR CUP, # 74120156, LOT # 07GW12667| ACETABULAR CUP, # 74120156, LOT # UNKNOWN| ACETABULAR CUP, # 74120156, LOT # UNKNOWN