BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH KNEE FEM XS RHT

    MDR report key: 3180429 · Received June 20, 2013

    Report

    Report Number
    0002249697-2013-02002
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). THE REPORTED LOT NUMBER IS INVALID AND COULD NOT BE IDENTIFIED ON THE RETURNED DEVICE, AS IT WAS COVERED IN BONE CEMENT. AN EVENT REGARDING FRACTURE OF A MRH FEMORAL KNEE COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL AND MATERIAL ANALYSIS CONFIRMED THE REPORTED EVENT. THE FEMORAL COMPONENT WAS FRACTURED THROUGH THE LATERAL CONDYLAR SECTION AND ON THE THREADED BOSS. THE MRH FEMORAL COMPONENT BROKE IN FATIGUE. THE PROXIMAL BOSS MOST LIKELY FAILED IN FATIGUE POST FRACTURE OF THE LATERAL CONDYLAR SURFACE. NO MANUFACTURING OR MATERIAL DEFECTS WERE OBSERVED. THE INVESTIGATION CONCLUDED THAT THE LATERAL CONDYLE OF THE FEMORAL COMPONENT BROKE IN FATIGUE. AFTER THIS FRACTURE, THE STEM EXTENDER CARRIED MORE OF THE LOAD OF THE CONSTRUCT, CAUSING FRACTURE AT THE THREADED BOSS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE MEDICAL RECORDS, INCLUDING OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY, AND FOLLOW-UP NOTES WERE NOT PROVIDED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280571 MRH KNEE FEM XS RHT IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH 6508220001000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention