BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MERIDIAN BEADED ST STEM

    MDR report key: 2171344 · Received July 18, 2011

    Report

    Report Number
    9616680-2011-00480
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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

    IT WAS REPORTED THAT, "THE DOCTOR INFORMED THE REP ON (B)(6) 2011 THAT THE NECK OF THE STEM BROKE INSIDE THE PT. THE STEM SNAPPED WHERE THE SKIRT OF THE HEAD AND THE NECK OF THE STEM MEET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MERIDIAN BEADED ST STEM IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention