BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIDING CORE UHMPWE, 8MM

    MDR report key: 5334359 · Received December 30, 2015

    Report

    Report Number
    0008031020-2015-00848
    Event Type
    Injury
    Date Received
    December 30, 2015
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    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 GMBH, (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM (B)(4). THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4)., (B)(4) AND IMPLANTED PRIOR TO (B)(4) PURCHASE OF CERTAIN ASSETS OF SBI ON (B)(4) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(4) 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.

    Description of Event or Problem · 1

    REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857960 SLIDING CORE UHMPWE, 8MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1250137

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention