BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOWED CONICAL STEM 15 X 195MM RESTORATION MODULAR

    MDR report key: 2896179 · Received December 28, 2012

    Report

    Report Number
    9616680-2012-01522
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K022549
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS UNCLEAR WHAT HAPPENED TO THE PT BUT WITH THEIR RETURN THEY HAD BROKEN THE DISTAL STEM OF THE RESTORATION MODULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOWED CONICAL STEM 15 X 195MM RESTORATION MODULAR IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA CAXJ452D

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R