BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC TOTAL FEMUR

    MDR report key: 7785352 · Received August 15, 2018

    Report

    Report Number
    3004105610-2018-00071
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    July 20, 2018
    Report Date
    January 29, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K140900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: DEVICE NAME HAS BEEN CORRECTED FROM TIBIAL COMPONENT TO PATIENT SPECIFIC TOTAL FEMUR. PMA/510K HAS BEEN CORRECTED FROM K121055 TO K140900. ADDITIONAL INFORMATION: AN EVENT REGARDING ALLEGED FRACTURED TIBIAL COMPONENT INVOLVING A CUSTOM TOTAL FEMUR WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. CLINICIAN REVIEW: THE IMPLANT IN SITU WAS FOR A CUSTOM TOTAL FEMORAL REPLACEMENT, ARTICULATED WITH A ROTATING HINGE SMILES KNEE JOINT, WHICH WAS INSERTED ON (B)(6) 1999. THE X-RAY PROVIDED SHOWS THE FRACTURE OF THE TIBIAL STEM UNDERNEATH THE TIBIA TRAY. THEREFORE, THIS CONFIRMS THE REASON FOR REVISION. THE REPORTED INCIDENT COULD BE DUE TO INADEQUATE FORCE ACROSS THE KNEE JOINT, CAUSING THE FATIGUE FRACTURE ON THE TIBIAL STEM. THIS MAY BE DUE TO THE PATIENT¿S BODY WEIGHT, OR ACTIVITY LEVEL. HOWEVER, FURTHER INVESTIGATION MAY BE NECESSARY ON THE IMPLANT WHEN/IF THE DEVICE IS RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 10AUG1999 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS. CONCLUSIONS: THE INVESTIGATION INDICATED THAT THE TIBIAL COMPONENT OF A CUSTOM DISTAL FEMUR THAT HAD BEEN IMPLANTED FOR 19 YEARS HAD FRACTURED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE RETURN OF THE DEVICE, THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION WAS REQUIRED FOR A CASE OF A RIGHT TOTAL FEMUR WITH CUSTOM MADE FEMUR AND A BROKEN TIBIAL COMPONENT. THE PATIENT CONTACTED HIS DOCTOR A WEEK AGO BECAUSE HE HEARD A CRACKING NOISE COMING FROM HIS KNEE WHILE WALKING AND IT BECAME IMMEDIATELY UNSTABLE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS REQUIRED FOR A CASE OF A RIGHT TOTAL FEMUR WITH CUSTOM MADE FEMUR AND A BROKEN TIBIAL COMPONENT. THE PATIENT CONTACTED HIS DOCTOR A WEEK AGO BECAUSE HE HEARD A CRACKING NOISE COMING FROM HIS KNEE WHILE WALKING AND IT BECAME IMMEDIATELY UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627291 PATIENT SPECIFIC TOTAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE PIN 6619

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R