BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO CR WAFFLE FEMUR LFIT W/POSTS

    MDR report key: 4221768 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04159
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K974556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: SECTION D INFORMATION HAS BEEN CORRECTED BASED UPON THE RECEIPT OF THE ACTUAL DEVICE FOR EVALUATION. AN EVENT REGARDING CRACK/FRACTURE INVOLVING A SCORPIO CR WAFFLE FEMUR LFIT W/POSTS WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSION: METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE RETURNED DEVICE SHOWED SIGNS OF USE. THE FEMORAL COMPONENT WAS FRACTURED THROUGH THE MEDIAL CONDYLE. DAMAGES ASSOCIATED WITH THE FEMORAL COMPONENT WERE OBSERVED ON THE TIBIAL INSERT. MEDICAL RECORDS RECEIVED AND EVALUATION: "NO DOCUMENTATION WAS PROVIDED AS TO WHAT LEAD TO THE REVISION. THE REPORT FROM THE MATERIAL ANALYSIS NOTES THE IMPLANT FRACTURED IN FATIGUE WITH THE FRACTURE INITIATING ON THE LATERAL SIDE OF THE ARTICULATING SURFACE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. NO SUPPORTING EVIDENCE I.E., PRE OPERATIVE XRAYS, WERE PROVIDED WHICH WOULD PROVIDE FURTHER INSIGHT IN TO THE REASONS FOR IMPLANT FATIGUE. SEVERAL COPIES OF B&W INTRAOPERATIVE PHOTOS DEMONSTRATE THE PATIENT HAD A LARGE BODY HABITUS. NO CONCLUSION ABOUT THE INTEGRITY OF THE SUPPORTING BONE BENEATH THE IMPLANT CAN BE MADE.. DEVICE HISTORY REVIEW: A REVIEW OF THE DHR SHOWED THAT ALL DEVICES WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT INVOLVES FRACTURE OF THE A SCORPIO FEMORAL COMPONENT. REVIEW OF THE MEDICAL RECORDS INDICATED THAT THE "PATIENT UNDERWENT A STANDARD RIGHT TKA IN 2006 WITH A SCORPIO TKA. NO CLINICAL DOCUMENTATION IS OFFERED OTHER THAN AN INTERIM TOTAL BODY BONE SCAN PERFORMED IN 2010 FOR ISSUES UNRELATED TO THE KNEE NO EVIDENCE OF IMPLANT PROBLEMS WERE NOTED AT THAT TIME. KNEE XRAYS TAKEN AFTER A FALL IN 2011 AGAIN SHOWED NO IMPLANT ISSUES. CLINICAL NOTE IN THIS REPORT OF INTERMITTENT RIGHT KNEE PAIN. IN 2014 THE PATIENT UNDERWENT A REVISION TKA ¿ NO DOCUMENTATION WAS PROVIDED AS TO WHAT LEAD TO THE REVISION." THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. IN ORDER TO COMPLETE A FULL INVESTIGATION, ITEMS SUCH AS PRE-OPERATIVE REPORTS AND X-RAYS ARE NEEDED TO DETERMINE THE ROOT CAUSE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE SURGERY REPORTS AND X-RAYS WERE REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON OF THE HOSPITAL, THAT THE IMPLANT IS BROKEN. IMPLANTATION WAS IN 2006.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON OF THE HOSPITAL, THAT THE IMPLANT IS BROKEN. IMPLANTATION WAS IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703954 SCORPIO CR WAFFLE FEMUR LFIT W/POSTS IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH K06A300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R