BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 5291180 · Received December 11, 2015

    Report

    Report Number
    0008031020-2015-00493
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    July 7, 2011
    Report Date
    November 17, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF SBI ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. UNKNOWN STAR TALAR COMPONENT: MEDIUM (36MM X 35MM), RIGHT... DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AFTER THE STAR SURGERY, THE SUBJECT COMPLAINED OF DELAYED WOUND HEALING (2005), SENSORY DEFICIT (2006), AND TIA SECONDARY TO A-FIB (2009). AFTER THE ONSET OF THIS PAIN EVENT, THE PATIENT REPORTED EXPERIENCING PROSTATE CANCER, AND PAIN OVER MEDIAL MALLEOLUS (2013).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819250 UNKNOWN_SELZACH_PRODUCT PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 021126/0543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other