BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM CEMENTED STEM TRIAL BOWED-203MM

    MDR report key: 3030338 · Received April 2, 2013

    Report

    Report Number
    0002249697-2013-01163
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION - RESULTS.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT INVOLVING AN MRS TRIAL STEM WAS REPORTED. THE REPORTED LENGTH DISCREPANCY BETWEEN TRIAL AND IMPLANT COMPONENTS ONLY CONCERNS THE TRIAL EXTENSION PIECES. THERE IS NO EVIDENCE THAT THERE IS A LENGTH DISCREPANCY BETWEEN THE MRS TRIAL STEM AND ITS CORRESPONDING IMPLANT STEM. THE AFFECTED TRIAL EXTENSION PIECES WITHIN THE PI WILL UNDERGO FURTHER INVESTIGATIONS. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT AND IS THEREFORE CONSIDERED CONCOMITANT.

    Description of Event or Problem · 1

    TRIALS DID NOT MATCH IMPLANTS.

    Description of Event or Problem · 1

    TRIALS DID NOT MATCH IMPLANTS.

    Description of Event or Problem · 1

    TRIALS DID NOT MATCH IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135238 11MM CEMENTED STEM TRIAL BOWED-203MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TAXE405

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other