BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR RESURFACING FEMORAL HEAD 48MM

    MDR report key: 8128261 · Received December 4, 2018

    Report

    Report Number
    3005975929-2018-00521
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    December 12, 2018
    Report Date
    April 24, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010552426
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: [C-0221029.PDF]

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. SURGEON ADVISED (B)(6)2019 ¿THIS CASE WAS A PURELY FEMORAL LOOSENING OF THE BHR AFTER MORE THAN 10 YEARS. IN MY OPINION, THIS IS NOT AN IMPLANT FAILURE BUT A "NORMAL LOOSENING".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY IS SCHEDULED TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968141 BHR RESURFACING FEMORAL HEAD 48MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08GW17948 03596010552426

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R ACETABULAR CUP, # 74122154, LOT # 08JW18972| ACETABULAR CUP, # 74122154, LOT # 08JW18972