BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI CUP STANDARD

    MDR report key: 3012579 · Received March 20, 2013

    Report

    Report Number
    9613369-2013-00024
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SMITH&NEPHEW - SWITZERLAND
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115233 HI CUP STANDARD HI-LUBRICER SHELL INCL. COVER 4/37 JDG SMITH&NEPHEW - SWITZERLAND C1130268

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R (B)(4) - CERA INS STD. 3-5/28 LOT NO: 10©685341| (B)(4) - BIOLOX OPTION 28XL - LOT NO: 10©28166| (B)(4) - COVER FOR SHELL 3-5 -LOT NO: CXB00011