BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR MODULAR HEAD 46MM

    MDR report key: 8589831 · Received May 8, 2019

    Report

    Report Number
    3005975929-2019-00197
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 29, 2019
    Report Date
    November 12, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    KWY
    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: [233084 SUMMARY.PDF]

    Description of Event or Problem · 1

    LEFT HIP REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384855 BHR MODULAR HEAD 46MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY SMITH & NEPHEW ORTHOPAEDICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R MODULAR SLEEVE, # 74222100, LOTT # UNKNOWN| MODULAR SLEEVE, # 74222100, LOTT # UNKNOWN