BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - GRUB SCREW

    MDR report key: 9806324 · Received March 9, 2020

    Report

    Report Number
    3004105610-2020-00053
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 10, 2020
    Report Date
    April 16, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT AN EVENT REGARDING ALLEGED COLLAPSING INVOLVING A MIG DISTAL FEMORAL REPLACEMENT 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 MIG DISTAL FEMORAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2013 AND THE SCREW WAS CHANGED IN (B)(6) 2017. THE CLINICIAN REPORTED THAT THE IMPLANT HAS BEEN EXTENDED TO ITS MAXIMUM (THE IMPLANT WAS DESIGNED TO HAVE MAXIMUM EXTENSION OF 85 MM) BUT COLLAPSED AFTERWARD. AS THE RESULT, THE LEG IS SHORTER. THE MEASUREMENT X-RAY PROVIDED SHOWED THAT THE IMPLANT IS 35 MM EXTENDED AND THE AFFECTED LEG IS AROUND 35 ¿ 40 MM SHORTER THAN THE OPPOSITE LEG, ALTHOUGH THE REASON FOR THE IMPLANT COLLAPSE CANNOT BE ASSESSED RADIOGRAPHICALLY. THEREFORE, THE X-RAY REVIEW CAN CONFIRM THE CLINICAL REPORT. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE ENTER 1 WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 19JUL2017 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 01JAN2017 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING MIG DEVICE'S COLLAPSING INVOLVING LOCKING SCREW. THERE HAS BEEN 1 OTHER EVENT. CONCLUSIONS: AN EVENT REGARDING ALLEGED COLLAPSING INVOLVING A MIG DISTAL FEMORAL REPLACEMENT WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. THE SALES REP REPORTED THAT THE SCREW THREADED DURING THE LAST LENGTHENING PROCEDURE AND THIS COULD HAVE CAUSED THE DEVICE TO COLLAPSE. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS RETRIEVAL OF 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 IMPLANT FORM WAS RECEIVED WITH THE DIAGNOSIS OF REVISION FOR PREVIOUS PIN 17972 FOR THE PATIENT'S DISTAL FEMUR MINIMALLY INVASIVE GROWER. "HE HAS CONCERTINAED DOWN. HE IS AT THE POINT NOW WHERE HE CANNOT LENGTHEN ANY MORE BUT HAS LOST APPROXIMATELY 3.5CM IN LENGTH" IT HAS BEEN FURTHER REPORTED THAT "THE LOCKING SCREW WAS REPLACED WITH PIN 20900 IN (B)(6) 2017. THE REPLACEMENT SCREW CROSS THREADED AT THE LAST LENGTHENING WHICH MAY HAVE CONTRIBUTED TO THE FEMUR COLLAPSING".

    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. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A PATIENT SPECIFIC IMPLANT FORM WAS RECEIVED WITH THE DIAGNOSIS OF REVISION FOR PREVIOUS PIN 17972 FOR THE PATIENT'S DISTAL FEMUR MINIMALLY INVASIVE GROWER. "HE HAS "CONCERTINAED" DOWN. HE IS AT THE POINT NOW WHERE HE CANNOT LENGTHEN ANY MORE BUT HAS LOST APPROXIMATELY 3.5CM IN LENGTH". IT HAS BEEN FURTHER REPORTED THAT "THE LOCKING SCREW WAS REPLACED WITH PIN 20900 IN (B)(6) 2017. THE REPLACEMENT SCREW CROSS THREADED AT THE LAST LENGTHENING WHICH MAY HAVE CONTRIBUTED TO THE FEMUR COLLAPSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270943 DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - GRUB SCREW PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 20900

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other