BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    MDR report key: 8109647 · Received November 28, 2018

    Report

    Report Number
    3004105610-2018-00150
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    November 16, 2018
    Report Date
    April 30, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K092138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1 - DISTAL FEMORAL COMPONENT TO PROXIMAL TIBIA JTS. B5 - LEFT SIDE TO RIGHT SIDE. G5 - K140898 TO K092138. ADDITIONAL MANUFACTURER NARRATIVE: REPORTED EVENT: AN EVENT REGARDING ALLEGED RECURRENCE OF OSTEOSARCOMA IN THE PATIENTS FEMUR, INVOLVING A JTS PROXIMAL TIBIA WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE IMPLANT IN SITU WAS FOR A JTS PROXIMAL TIBIA REPLACEMENT THE DATE OF INSERTION IS UNKNOWN. THE SURGEON REPORTED TUMOUR PROGRESSION IN THE DISTAL FEMUR. THE CT SCAN SHOWS SIGNS OF TUMOUR AND PERIOSTEUM REACTION WHICH CONFIRMS THE RECURRENCE OF THE TUMOUR AND THE REASON FOR REVISION. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 18OCT2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN 1 OTHER EVENT RELEVANT TO THIS INVESTIGATION. CONCLUSIONS: DUE TO A REPORTED RECURRENCE OF OSTEOSARCOMA IN THE FEMUR THE SURGEON REQUESTED A CUSTOM DISTAL FEMORAL REPLACEMENT TO COUPLE TO THE JTS PROXIMAL TIBIAL REPLACEMENT IN SITU. THE SURGEON HAS NOT ALLEGED ANY FAILURE OF THE SIW IMPLANT, THE REPORTED ISSUE IS DISEASE PROGRESSION. THE EXACT CAUSE OF THE RECURRENCE OF TUMOUR 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 IS REQUIRED 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. CORRECTIVE ACTION/PREVENTATIVE 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 HAS BEEN REPORTED THAT A REVISION IS REQUIRED WITH NOTES THAT STATE: " THE PATIENT HAS A TUMOR PROGRESSION IN DISTAL FEMUR (RIGHT SIDE)."

    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 HAS BEEN REPORTED THAT A REVISION IS REQUIRED WITH NOTES THAT STATE:"...THE PATIENT HAS A TUMOR PROGRESSION IN DISTAL FEMUR (LEFT SIDE)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949490 PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT) LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE PIN 20365 PIN 20365

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R SMBPR00 BUMPER PAD B15394| SMBPR00(B15394)BUMPER PAD| SMBSH00 BUSHES B13864| SMBSH00(B13864)BUSHES| SMCAP01 AXLE CAP B15612| SMCAP01 AXLE CAP B16004| SMCAP01(B15612)AXLE CAP| SMCAP01(B16004)AXLE CAP| SMBPR00 BUMPER PAD (B)(4)| SMBSH00 BUSHES (B)(4)| SMCAP01 AXLE CAP (B)(4)| SMCAP01 AXLE CAP (B)(4)