BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMRS ROT HINGE AXLE

    MDR report key: 2471023 · Received February 24, 2012

    Report

    Report Number
    9610726-2012-00061
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT, "THE PT WAS PROGRESSIVELY A GENU RECURVATUM WITH LAXITY. IT WAS DECIDED TO PROCEED TO A PARTIAL REVISION SURGERY OF THE PROSTHESIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HMRS ROT HINGE AXLE IMPLANT HSH STRYKER ORTHOPAEDICS LIMERICK NA LZDFY1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention