BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33 9MM SYM MB PATELLA W PA

    MDR report key: 3875066 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02277
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K043374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MANUFACTURING DATE. WEIGHT WAS UPDATED. AN EVENT REGARDING CRACK/FRACTURE INVOLVING A 33 9MM SYM MB PATELLA W PA WAS REPORTED. THE EVENT WAS CONFIRMED. ACCORDING TO THE MATERIAL ANALYSIS REPORT OF THE RETURNED DEVICE, THE CAUSE OF THE FRACTURE COULD NOT BE DETERMINED. THERE IS ALSO BURNISHING AND DEFORMATION OF THE PATELLA INSERT AND ABRASION ON THE METAL COMPONENT. A DEVICE HISTORY REVIEW INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE REPORTED EVENT INVOLVES THE PATIENT FALLING AND THEN BEING REVISED DUE TO THE POLY BECOMING DISLOCATED FROM THE METAL BACKING. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS IT IS NOT POSSIBLE TO DETERMINE WHICH EVENT CAME FIRST: THE FRACTURE OF THE POLY OR THE DISSOCIATION OF THE POLY FROM THE METAL COMPONENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY ON RIGHT KNEE DUE TO A FALL THREE WEEKS AGO. THE 33X9 PRESS FIT PATELLA POLY BECAME DISLOCATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY ON RIGHT KNEE DUE TO A FALL THREE WEEKS AGO. A 33X9 PRESS FIT PATELLA POLY BECAME DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353363 33 9MM SYM MB PATELLA W PA IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH TAK6861

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention