BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - TIBIAL COMPONENT

    MDR report key: 10449536 · Received August 25, 2020

    Report

    Report Number
    3004105610-2020-00133
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    July 28, 2020
    Report Date
    March 22, 2021
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1, D4, D6A, H4. ADDITIONAL MANUFACTURER NARRATIVE: REPORTED EVENT: AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MIG, DISTAL FEMUR, TIBIAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED BY PRODUCT INSPECTION. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: THE TIBIAL COMPONENT OF A MIG DISTAL FEMUR RECEIVED, ALONGSIDE THE TIBIAL BEARING, BUSHING, BUMPER PAD, AXLE AND AXLE CAP. VISUAL INSPECTION OF THE RETURNED TIBIAL HINGE COMPONENT IDENTIFIED A FRACTURE AT UPPER THIRD OF THE COMPONENT. THE RIGHT SIDE OF THE COMPONENT THAT HELPS TO SECURE THE AXLE, IS BROKEN. A SIGNIFICANT PIECE OF THE COMPONENT HAS BROKEN OFF AND CORRESPONDING GROOVE LINES ARE PRESENT ON EACH THE FRACTURED PIECES. THE AXLE ITSELF SHOW DISCOLORATION ON THE UPPER THIRD ALSO, WHICH MAY CORRESPOND WITH THE POINT OF FRACTURE FOUND AT THE TIBIAL HINGE. THE AXLE ALSO SHOWS A FRACTURE AT THE FLANGE, THE PIECE THAT BROKE OFF WAS NOT RETURNED. THEREFORE, VISUAL INSPECTION OF THE AXLE CAP, BUSHING, TIBIAL BEARING, AND BUMPER PAD DID NOT IDENTIFY ANY DAMAGE OR NON-CONFORMITY RELEVANT TO THE REPORTED EVENT. MATERIAL ANALYSIS: A MATERIAL ANALYSIS HAS BEEN PERFORMED. THE REPORT CONCLUDED: VISUAL EXAMINATION CONFIRMED FRACTURE OF THE TIBIAL COMPONENT. STEREOLOGICAL AND ELECTRON MICROSCOPY EXAMINATION CONFIRMED THE TIBIAL COMPONENT FRACTURED IN FATIGUE. NO MANUFACTURING ISSUES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE FRACTURE OBSERVED. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: THE IMPLANT IN SITU WAS FOR A MIG DISTAL FEMORAL REPLACEMENT. THE SURGERY DATE FOR THE ORIGINAL IMPLANT IS 07 AUG 2013 BUT THE IMPLANT WAS REVISED IN MAY 2020. THE SURGEON REPORTED THAT THE AXLE WAS BROKEN. THE X-RAY IMAGES PROVIDED SHOW THAT THE FEMORAL COMPONENT WAS DISENGAGED WITH THE TIBIAL COMPONENT, THIS MAY DUE TO THE FRACTURE OF THE TIBIAL HINGE. THE AXLE WAS BACKED OUT AND THE AXLE CAP CAN BE SEEN ASIDE OF THE IMPLANT. THEREFORE, THE RADIOGRAPHIC REVIEW CANNOT CONFIRM THE CLINICAL REPORT BUT CAN CONFIRM THAT THE IMPLANT NEEDS TO BE REVISED. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER RELEVANT EVENTS FOR THE LOT REFERENCED CONCLUSION: THE MATERIAL ANALYSIS CONCLUDED THAT " [..] NO MANUFACTURING ISSUES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE FRACTURE OBSERVED". THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS AND PROGRESS NOTES, ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT PRESCRIPTION FORM WAS RECEIVED FOR THE PATIENT'S RIGHT MIG. REASON FOR REVISION: AXLE BROKEN AND PROVIDE AN OPTION FOR A TIBIAL COMPONENT. UPDATE (B)(6) 2020 - IT WAS ORIGINALLY REPORTED THAT THE AXLE HAD BROKEN. UPON REVIEW IT WAS DETERMINED THAT THE TIBIAL COMPONENT HAD BROKEN. UPDATE (B)(6) 2021: REVIEW OF THE VISUAL INSPECTION OF RETURNED DEVICES CONFIRMS A PREVIOUSLY UNIDENTIFIED FRACTURE AT THE AXLE FLANGE.

    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.

    Description of Event or Problem · 1

    A PATIENT SPECIFIC IMPLANT PRESCRIPTION FORM WAS RECEIVED FOR THE PATIENT'S RIGHT MIG. REASON FOR REVISION: AXLE BROKEN AND PROVIDE AN OPTION FOR A TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915960 DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG) - TIBIAL COMPONENT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 17972

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R