BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP 56MM

    MDR report key: 8499469 · Received April 10, 2019

    Report

    Report Number
    3005975929-2019-00164
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 27, 2019
    Report Date
    September 25, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010502599
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: [240119 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. PATIENT COMPLAINED OF PAIN AND SHIFTING WITH HER BHR HIP RESURFACING. INITIAL SURGERY (B)(6) 2008. SHOWED SIGNS OF METALOSIS IN SYNOVIUM IN AND AROUND THE HEAD, NECK AND CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295204 BHR ACETABULAR CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 03596010502599

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R FEMORAL HEAD, # 74121146, LOT # UNKNOWN| FEMORAL HEAD, # 74121146, LOT # UNKNOWN