BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 8070944 · Received November 14, 2018

    Report

    Report Number
    3004105610-2018-00115
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 22, 2018
    Report Date
    April 16, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1 - DEVICE TYPE PROXIMAL FEMORAL STEM TO DISTAL FEMUR JTS. D2 - JDI TO KRO. D6 - (B)(6) 2016. G5 - K121056 TO K133152. ADDITIONAL MANUFACTURER NARRATIVE: AN EVENT REGARDING ALLEGED LOOSENING INVOLVING A JTS DISTAL 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 JTS DISTAL FEMORAL REPLACEMENT WHICH WAS INSERTED AROUND (B)(6) 2016. THE SURGEON REPORTED LOOSENING OF THE IMPLANT AND HIGH RISK OF PERIPROSTHETIC FRACTURE. THE CT SCANS SHOW THAT THE BONE IS IN VERY POOR CONDITION WITH VERY CORTEX AND SEVERE BONE RESORPTION. THERE ARE RADIOLUCENT LINES IN THE STEM ¿ CEMENT INTERFACE AND ALSO BETWEEN THE CEMENT MANTLE AND THE BONE. THERE IS A POSSIBLE FRACTURE ON THE LATERAL AT THE BONE RESECTION LEVEL. THIS CONFIRMS THE REASON FOR REVISION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 11OCT2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 5 OTHER EVENTS RELEVANT TO THIS INVESTIGATION. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS 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. REVISION SURGERY TOOK PLACE ON (B)(6) 2018 DUE TO LOOSENING WHEREBY JTS DISTAL FEMUR COMPONENTS WERE EXPLANTED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE IS A NEED FOR A FEMORAL COMPONENT REVISION. IT WAS FURTHER REPORTED THAT THE PROXIMAL STEM IS LOOSE AND THERE IS HIGH RISK OF PERIPROSTHETIC FRACTURE.

    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 THERE IS A NEED FOR A FEMORAL COMPONENT REVISION. IT WAS FURTHER REPORTED THAT THE PROXIMAL STEM IS LOOSE AND THERE IS HIGH RISK OF PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909718 DISTAL FEMUR JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE PIN 20318 PIN 20318

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R