BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE UHMPWE, 8MM

    MDR report key: 5331628 · Received December 29, 2015

    Report

    Report Number
    0008031020-2015-00747
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    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

    WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(6) 2014.  STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED.  IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE IS NOT AVAILABLE TO STRYKER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE WAS ADDED.

    Description of Event or Problem · 1

    REVISION DUE TO OSTEOLYSIS, POLY WEAR.

    Description of Event or Problem · 1

    REVISION DUE TO OSTEOLYSIS, POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855509 SLIDING CORE UHMPWE, 8MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention