BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. MODULAR STEM

    MDR report key: 1924897 · Received December 8, 2010

    Report

    Report Number
    9616680-2010-00813
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092406
    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

    DR (B)(6), SURGEON FROM THE HOSPITAL, REPORTED VIA MR (B)(4), HIP PRODUCT MANAGER FROM STRYKER (B)(4), A TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6), 2009. DR (B)(4), SURGEON, FURTHER REPORTED THAT HE PERFORMED A REVISION ON (B)(4), 2010 DUE TO POTENTIAL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII. MODULAR STEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2836796

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention