BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESURFACING FEMORAL HEAD 54MM

    MDR report key: 6899971 · Received September 28, 2017

    Report

    Report Number
    3005975929-2017-00335
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    November 19, 2015
    Report Date
    July 24, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    KXA
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    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: [162343 SUMMARY.PDF]

    Additional Manufacturer Narrative · 1

    PART DETAILS IN SECTION AMENDED TO BETTER REFLECT CLARIFIED EVENT DESCRIPTION SUBSEQUENTLY RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ACETABULAR CUP REMAINED IMPLANTED. SUBSEQUENT REVISION CAPTURED VIA MDR 3005975929-2018-00098.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. SUBSEQUENT REVISION SURGERY INVOLVING UNSPECIFIED DEVICES (B)(6) 2017. METALLOSIS AND FLUID COLLECTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680298 RESURFACING FEMORAL HEAD 54MM PROSTHESIS, HIP, FEMORAL, RESURFACING KXA SMITH & NEPHEW ORTHOPAEDICS LTD 57921

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R ACETABULAR CUP, # 74120162, LOT # 54625R| FEMORAL HEAD, PART AND LOT # UNKNOWN| FEMORAL HEAD, PART AND LOT # UNKNOWN