BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 9400763 · Received December 3, 2019

    Report

    Report Number
    3004105610-2019-00126
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 6, 2019
    Report Date
    February 7, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS SIMILAR TO A DEVICE APPROVED FOR COMPASSIONATE USE IN THE UNITED STATES. REPORTED EVENT AN EVENT REGARDING FAILURE OF THE CEMENT MANTLE BETWEEN A HIP STEM AND A MIG DISTAL FEMUR WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD AND RESULTS PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RECEIVED. CLINICIAN REVIEW: THE IMPLANT IN SITU WAS FOR A MIG DISTAL FEMORAL REPLACEMENT, IN WHICH THE FEMORAL TUBE CEMENTED OVER THE DISTAL HIP STEM. THE SURGEON REPORTED THAT THIS CEMENT FIXATION HAS FAILED. THE CT SCAN PROVIDED SHOWED THAT THE HIP STEM IS TILTED MEDIALLY AND MISALIGNED WITH THE MIG COMPONENT, WHICH INDICATES THAT THE HIP STEM IS LOOSE INSIDE THE FEMORAL TUBE. HOWEVER, THE CEMENT MANTLE INSIDE THE TUBE CANNOT BE OBSERVED BECAUSE OF THE METAL WORK. THEREFORE, THE RADIOGRAPHIC ASSESSMENT CAN CONFIRM THE REASON FOR REVISION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 10MAY2017 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 01JAN2016 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING DISASSOCIATION FOR CEMENT FAILURE INVOLVING MIG DISTAL FEMUR. THERE HAVE BEEN NO OTHER EVENTS. CONCLUSIONS: AN EVENT REGARDING FAILURE OF THE CEMENT MANTLE BETWEEN A HIP STEM AND A MIG DISTAL FEMUR WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS RETRIEVAL ANALYSIS 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/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 RIGHT TOTAL FEMUR. DIAGNOSIS IS "FAILED MODULAR TOTAL FEMORAL REP". NOTE INDICATE "CURRENT IMPLANTS ARE STANDARD FIXED HINGE TIBIAL COMPONENT, CUSTOM DISTAL FEMORAL GROWING COMPONENT WITH FEMORAL STEM CEMENTED INTO CONSTRUCT PROXIMALLY". ADDITIONAL NOTES STATE "REVISION OF ALL COMPONENTS PLANNED. PATIENT CURRENTLY HAS SHORTENING ++ OF RIGHT LOWER LIMB. CAPACITY TO LENGTHEN FROM CURRENT CONSTRUCT LENGTH BY APPROX 1.5CM" THE REQUIRED BY DATE IS INDICATED AS ASAP. UPDATE 14NOV2019 - AS REPORTED BY THE SALES REP, "PATIENT DIDN¿T HAVE ANYTHING REVISED ON THE 6TH [...] (IMPLANT TO BE REVISED) DUE TO A FAILED CEMENT OVER MIG OVER A HIP STEM"

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS SIMILAR TO A DEVICE APPROVED FOR COMPASSIONATE USE IN THE UNITED STATES. 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

    A PATIENT SPECIFIC PRESCRIPTION FORM WAS SUBMITTED FOR PATIENT'S RIGHT TOTAL FEMUR. DIAGNOSIS IS "FAILED MODULAR TOTAL FEMORAL REP". NOTE INDICATE "CURRENT IMPLANTS ARE STANDARD FIXED HINGE TIBIAL COMPONENT, CUSTOM DISTAL FEMORAL GROWING COMPONENT WITH FEMORAL STEM CEMENTED INTO CONSTRUCT PROXIMALLY". ADDITIONAL NOTES STATE "REVISION OF ALL COMPONENTS PLANNED. PATIENT CURRENTLY HAS SHORTENING ++ OF RIGHT LOWER LIMB. CAPACITY TO LENGTHEN FROM CURRENT CONSTRUCT LENGTH BY APPROX 1.5CM" THE REQUIRED BY DATE IS INDICATED AS ASAP. UPDATE (B)(6) 2019 - AS REPORTED BY THE SALES REP, "PATIENT DIDN¿T HAVE ANYTHING REVISED ON THE (B)(6). (IMPLANT TO BE REVISED) DUE TO A FAILED CEMENT OVER MIG OVER A HIP STEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196093 DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 19997

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R