BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP HAP SIZE 52/58

    MDR report key: 6185038 · Received December 19, 2016

    Report

    Report Number
    3005975929-2016-00070
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    August 12, 2015
    Report Date
    January 21, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT & OTHER CORRECTED FOLLOWING RECEIPT OF OPERATIVE REPORTS. 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: [130389 SUMMARY.PDF]

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Description of Event or Problem · 1

    PAIN *US LEGAL CLAIM* IT WAS REPORTED REVISION SURGERY OCCURRED DUE TO HIP PAIN AND OTHER COMPLICATIONS. (NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838546 BHR ACETABULAR CUP HAP SIZE 52/58 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 10LW30828

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R RESURFACING FEMORAL HEAD 52MM PART & LOT UNKNOWN| RESURFACING FEMORAL HEAD 52MM PART & LOT UNKNOWN