BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH KNEE FEM XS LFT

    MDR report key: 3110159 · Received May 13, 2013

    Report

    Report Number
    0002249697-2013-01660
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: THE MRH FEMORAL COMPONENT BROKE IN FATIGUE. FROM THE ORIENTATION OF THE FATIGUE STRIATIONS THE FRACTURE INITIATED AT THE BASE OF THE BOSS PROGRESSING IN AN ANTERIOR DIRECTION AND THEN CHANGED DIRECTION AND PROGRESSED PROXIMALLY TO FAILURE. EDS SHOWED THE MRH FEMORAL COMPONENT TO BE MADE OF (B)(4). NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED DURING THIS EVALUATION. MEDICAL REVIEW COMPLETED INDICATED THAT AN OVERLOAD AND SUBSEQUENT FATIGUE FAILURE OCCURRED THROUGH ABSENCE OF BONY SUPPORT BELOW THE MRH FEMORAL CONDYLAR SECTION THROUGH AN EXCESSIVELY THICK CEMENT MANTLE. MATERIAL ANALYSIS COMPLETED ON THE RETURNED DEVICE INDICATED THAT THE FEMORAL CONDYLE BROKE IN FATIGUE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFECTS. HOWEVER, THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT CLINICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS CLINICAL OR PAST MEDICAL HISTORY, OPERATIVE REPORTS AND SERIAL X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN AND IT WAS OBSERVED THAT THE IMPLANT WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN AND IT WAS OBSERVED THAT THE IMPLANT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211077 MRH KNEE FEM XS LFT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention