BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3030620 · Received April 2, 2013

    Report

    Report Number
    3005477969-2013-00127
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    July 25, 2012
    Report Date
    March 12, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS SUBMITTED MDRS REFERENCED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, WHICH STARTED FOLLOWING IMPLANTATION AND THEN WORSENED. CLUNKING, SQUEAKING AND LIMPING ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134263 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 61013

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL STEM, # 71356007, LOT# 06AM02378B| HEMI HEAD, PART# 74122546, LOT# 10033| MODULAR SLEEVE, PART# 74223200, LOT# 9767