BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM. INSERT

    MDR report key: 1924878 · Received December 8, 2010

    Report

    Report Number
    9616680-2010-00814
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    September 27, 2010
    Report Date
    November 25, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K072020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SURGEON FROM THE HOSPITAL REPORTED THAT A REVISION WAS PERFORMED ON SEPTEMBER DUE TO INTROPROSTHETIC DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM. INSERT IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G1386274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention