BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PE BEARING TRIAL STAR ANKLE 6MM

    MDR report key: 5328829 · Received December 28, 2015

    Report

    Report Number
    0008031020-2015-00658
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    April 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    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 (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), HOWMEDICA OSTEONICS CORP.¿S PURCHASED CERTAIN ASSETS OF (B)(4) ON AUGUST 1, 2014.  STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 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.

    Description of Event or Problem · 1

    DAMAGED POLY TRIAL / BROKEN FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853355 PE BEARING TRIAL STAR ANKLE 6MM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 1124311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other