BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3171774 · Received June 17, 2013

    Report

    Report Number
    3005477969-2013-00241
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273230 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 10379

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R SCREW, PART# 71332545, LOT# 01GM05108| SCREW, PART# 71332525, 07JM07883 & 07GT11143| SCREW, PART# 71332530, LOT# 07HM18807| ACETABULAR SHELL, PART# 71330006, LOT# 06JM09486| FEMORAL STEM, PART# 71357009, LOT# 07EM02651A| FEMORAL HEAD, PART#74222142, LOT# 07KW14189| MODULAR HEAD SLEEVE PART #74222200, LOT #07LW14969