BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4241389 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04220
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN SCORPIO FEM. WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING LOOSENING INVOLVING A SCORPIO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. MEDICAL RECORDS RECEIVED AND EVALUATION: PROVIDED X-RAYS WERE REVIEWED BY A CONSULTING CLINICIAN WHO CONFIRMED THE REPORTED LOOSENING. NO ADDITIONAL CONCLUSIONS CAN BE MADE WITHOUT CLINICAL HISTORY AND OPERATIVE REPORTS. DEVICE HISTORY REVIEW: NOT PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED FOR REVIEW. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO PRODUCT INFORMATION WAS PROVIDED FOR REVIEW. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO PRODUCT INFORMATION OR PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    STRYKER SCORPIO LEFT KNEE CR IMPLANTED 14 YEARS AGO REVISED TO A TRIATHLON TS DUE TO LOOSENING.

    Description of Event or Problem · 1

    STRYKER SCORPIO LEFT KNEE CR IMPLANTED 14 YEARS AGO REVISED TO A TRIATHLON TS DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721695 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention