BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP HAP

    MDR report key: 4853203 · Received June 18, 2015

    Report

    Report Number
    3005477969-2015-00175
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    October 1, 2013
    Report Date
    June 4, 2015
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PAIN A (B)(6) LEGAL CLAIM (B)(6) WAS RECEIVED. REVISION SURGERY RIGHT HIP DUE TO PAIN AND PROBABLE METAL ON METAL REACTION. INTRAOPERATIVELY THERE WAS FOUND ADVERSE REACTION TO METAL DEBRIS IN THE SOFT TISSUES AROUND THE FEMORAL STEM PROXIMALLY AS WELL AS AROUND THE ACETABULUM. IN THE ACETABULUM WAS A COMPLETE LOSS OF ANTERIOR WALL. MEDIAL WALL THERE WAS TWO LARGE CAVITIES ON THE SUPERIOR ASPECT OF THE ACETABULUM CONTAINING DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396359 BHR ACETABULAR CUP HAP PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 51561

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R