BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDSHAFT FEMUR MINIMALLY INVASIVE GROWER (MIG) - LOCKING SCREW

    MDR report key: 12116403 · Received July 5, 2021

    Report

    Report Number
    3004105610-2021-00102
    Event Type
    Malfunction
    Date Received
    July 5, 2021
    Date of Event
    June 9, 2021
    Report Date
    January 20, 2022
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISASSOCIATION INVOLVING A MIG, MIDSHAFT FEMUR, SCREW AS REPORTED. THE EVENT WAS CONFIRMED BY X RAY REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED CLINICIAN REVIEW: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: THE IMPLANT IN SITU WAS FOR MIG MID-SHAFT JOINT SAVER FEMORAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2011. THE SURGEON REPORTED A LOOSE METAL PIECE FLOATING IN THE JOINT SPACE. THE IMAGE PROVIDED SHOWS THAT A MIG LOCKING SCREW WAS FLOATING BETWEEN THE FEMORAL CONDYLES AND TIBIAL PLATEAU OF THE KNEE JOINT. THEREFORE, THE RADIOGRAPHIC REVIEW CAN CONFIRM THE CLINICAL REPORT AND REASON FOR REVISION. 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 EVENTS FOR THE LOT REFERENCED CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PATHOLOGY REPORTS, PROGRESS NOTES, AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 0

    UPDATE TO CORRECTIVE ACTION/PREVENTIVE ACTION REPORTED EVENT: AN EVENT REGARDING DISASSOCIATION INVOLVING A MIG, MIDSHAFT FEMUR, SCREW AS REPORTED. THE EVENT WAS CONFIRMED BY X RAY REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED CLINICIAN REVIEW: A REVIEW OF THE PROVIDED X-RAYS BY A CLINICAL CONSULTANT INDICATED: THE IMPLANT IN SITU WAS FOR MIG MID-SHAFT JOINT SAVER FEMORAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2011. THE SURGEON REPORTED A LOOSE METAL PIECE FLOATING IN THE JOINT SPACE. THE IMAGE PROVIDED SHOWS THAT A MIG LOCKING SCREW WAS FLOATING BETWEEN THE FEMORAL CONDYLES AND TIBIAL PLATEAU OF THE KNEE JOINT. THEREFORE, THE RADIOGRAPHIC REVIEW CAN CONFIRM THE CLINICAL REPORT AND REASON FOR REVISION. 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 EVENTS FOR THE LOT REFERENCED CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PATHOLOGY REPORTS, PROGRESS NOTES, AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: IN 2017, SIW INITIATED A FIELD SAFETY NOTICE (FSN) THAT RESULTED IN ADDITIONAL WARNINGS TO THE MIG IFU (RELEASED PRIOR 2014) TO REDUCE ANY POTENTIAL COMPLICATIONS FOR THE MIG, LEAD SCREW, LOCKING MECHANISM. THE REPORTED PRODUCT OF THIS INVESTIGATION WAS MANUFACTURED AND INSERTED BEFORE THE IFU UPDATE.

    Description of Event or Problem · 0

    AN X-RAY OF A PATIENT'S LEFT KNEE WAS RECEIVED WITH A PIECE OF METAL FLOATING IN THE JOINT SPACE. ENGINEERING CONFIRMED THE PIECE IS THE LOCKING SCREW OF THE MIDSHAFT FEMUR MIG.

    Description of Event or Problem · 0

    AN X-RAY OF A PATIENT'S LEFT KNEE WAS RECEIVED WITH A PIECE OF METAL FLOATING IN THE JOINT SPACE. ENGINEERING CONFIRMED THE PIECE IS THE LOCKING SCREW OF THE MIDSHAFT FEMUR MIG.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS SIMILAR TO A DEVICE APPROVED FOR COMPASSIONATE USE IN THE UNITED STATES. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 1

    AN X-RAY OF A PATIENT'S LEFT KNEE WAS RECEIVED WITH A PIECE OF METAL FLOATING IN THE JOINT SPACE. ENGINEERING CONFIRMED THE PIECE IS THE LOCKING SCREW OF THE MIDSHAFT FEMUR MIG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013968 MIDSHAFT FEMUR MINIMALLY INVASIVE GROWER (MIG) - LOCKING SCREW PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 16485

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other