BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR (STANMORE KNEE)

    MDR report key: 6010423 · Received October 7, 2016

    Report

    Report Number
    3004105610-2016-00089
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE INCIDENT. A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    AN X-RAY REVIEW WAS PERFORMED WHICH CONFIRMED THE REPORTED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THERE IS NO INDICATION THAT THE OBSERVED LOOSENING WAS DEVICE RELATED AS NO DEVICE OR MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. IT IS NOTED THAT THE SUBJECT DEVICE HAD BEEN IMPLANTED FOR 14 YEARS. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION OF THE PROXIMAL TIBIAL COMPONENT OF A DISTAL FEMUR STANMORE KNEE. THE COMPLAINT IS IN REFERENCE TO A DEVICE THAT HAD BEEN IMPLANTED FOR 14 YEARS PRIOR TO THIS COMPLAINT. A DEFINITIVE ROOT CAUSE OF THE ASEPTIC LOOSENING HAS NOT BEEN IDENTIFIED. REQUESTS WERE MADE FOR FURTHER INFORMATION IN RELATION TO THIS INCIDENT HOWEVER THE REQUESTED INFORMATION WAS NOT PROVIDED TO STANMORE IMPLANTS WORLDWIDE (SIW). FURTHER INFORMATION SUCH AS PRODUCT DETAILS, PRODUCT RETURN, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. ASEPTIC LOOSENING IS HOWEVER A WELL-KNOWN MODE OF FAILURE FOR ORTHOPEDIC IMPLANTS, WHICH MAY OCCUR AS AN EARLY OR A LATE COMPLICATION. THERE WERE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION SURGERY. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    (B)(4). A NEW PRESCRIPTION FORM WAS RECEIVED REQUESTING A PROXIMAL TIBIA DESIGN TO MATCH THE EXISTING DISTAL COMPONENT DUE TO LOOSENING.

    Description of Event or Problem · 1

    A NEW PRESCRIPTION FORM WAS RECEIVED REQUESTING A PROXIMAL TIBIA DESIGN TO MATCH THE EXISTING DISTAL COMPONENT DUE TO LOOSENING. THIS IS A SUPPLEMENTAL REPORT TO 33004105610-2016-00089 (B)(4).

    Description of Event or Problem · 1

    A NEW PRESCRIPTION FORM WAS RECEIVED REQUESTING A PROXIMAL TIBIA DESIGN TO MATCH THE EXISTING DISTAL COMPONENT DUE TO LOOSENING. THIS IS THE SECOND SUPPLEMENTAL REPORT TO 33004105610-2016-00089 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662971 DISTAL FEMUR (STANMORE KNEE) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 9201 PIN 9201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention