BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER FEMORAL STEM + 2 PMMA CENTRALISERS 37.5MM

    MDR report key: 2061236 · Received April 11, 2011

    Report

    Report Number
    9616680-2011-00194
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K891454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE PT FEMORAL EXETER STEM CRACKED AT MID-LEVEL OF THE STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER FEMORAL STEM + 2 PMMA CENTRALISERS 37.5MM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA GX305457

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention