BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE UHMPWE, 8MM

    MDR report key: 5333279 · Received December 29, 2015

    Report

    Report Number
    0008031020-2015-00791
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    March 18, 2014
    Report Date
    March 21, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED.  IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISION TO ADDRESS DJD, POLY EXCHANGED DURING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856811 SLIDING CORE UHMPWE, 8MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 0931063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention