BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 8803132 · Received July 18, 2019

    Report

    Report Number
    3004105610-2019-00092
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    July 12, 2019
    Report Date
    October 23, 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: PROXIMAL FEMUR JTS TO DISTAL FEMUR JTS. D2: FROM JDI TO KRO. D2: COMMON DEVICE NAME FROM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED TO PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER. G5: K092138 TO K133152. ADDITIONAL MANUFACTURER NARRATIVE: AN EVENT REGARDING MIGRATION OF THE TIBIAL COMPONENT OF 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 A JTS DISTAL FEMORAL REPLACEMENT WHICH WAS INSERTED IN (B)(6) 2016. THE SURGEON HAS NOW REPORTED THAT THE TIBIAL COMPONENT HAS MIGRATED. THE X-RAY IMAGES PROVIDED HAS SHOWN THAT THE TIBIA STEM HAS TILTED IN WHICH THE TIP OF STEM HAS IMPINGED WITH THE LATERAL CORTEX OF THE TIBIA WHICH HAS CAUSED A DEFECT. THE ABOVE RADIOGRAPHIC ASSESSMENT HAS CONFIRMED THE REASON FOR REVISION." PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK 24FEB2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 15JUL2016 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING MALPOSITION OF JTS DISTAL FEMUR. THERE HAVE BEEN NO OTHER EVENTS. CONCLUSIONS: AN EVENT REGARDING MIGRATION OF THE TIBIAL COMPONENT OF A JTS DISTAL FEMUR WAS REPORTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS RETRIEVAL ANALYSIS ON THE EXPLANTED DEVICE AND 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/OR INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC PRESCRIPTION FORM WAS SUBMITTED FOR PATIENT'S LEFT DISTAL FEMUR. DIAGNOSIS IS "FEMORAL COMPONENT REVISION" DUE TO THE TIBIAL COMPONENT MIGRATION.

    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 EVALUATED BY MFR: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PATIENT SPECIFIC PRESCRIPTION FORM WAS SUBMITTED FOR PATIENT'S LEFT DISTAL FEMUR. DIAGNOSIS IS "FEMORAL COMPONENT REVISION" DUE TO THE TIBIAL COMPONENT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597539 DISTAL FEMUR JTS PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 19937

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R SMBPR00(B14878)BUMPER PAD.| SMBSH00(B14347)BUSHES.| SMCAP01(B13033)AXLE CAPS.| SMTBC00G(B15259)PASSIVE GROWER TIBIAL BEARING.