BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO 1

    MDR report key: 2885233 · Received December 18, 2012

    Report

    Report Number
    9616680-2012-01428
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT A BROKEN EXETER STEM HAD TO BE REMOVED FROM A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 44MM NO 1 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G1015514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R