BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR MODULAR HEAD 46MM

    MDR report key: 7163677 · Received January 4, 2018

    Report

    Report Number
    3005975929-2018-00010
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    December 6, 2017
    Report Date
    May 22, 2018
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    KWY
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Additional Manufacturer Narrative · 1

    CORRECTION COMES WITH AN ADDITIONAL NARRATIVE THAT THE REPORTED DEVICE HAS NOT BEEN CLEARED IN THE US. HOWEVER THE SLEEVE COMPONENT REPORTED HAS BEEN CLEARED IN THE US UNDER K062408.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO MUSCULAR LYSIS AND RECURRING LOOSENING OF THE PROSTHESIS - ALLERGIC REACTION TO A METAL ON METAL PROSTHESIS WITH PSEUDO TUMORAL MUSCULAR LYSIS SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8587 BHR MODULAR HEAD 46MM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED KWY SMITH & NEPHEW ORTHOPAEDICS LTD 08KW19589

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R MODULAR SLEEVE PLUS 0MM 12/14,7422220/08CW16018