BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HUMERAL REPLACEMENT MINIMALLY INVASIVE GROWER (MIG)

    MDR report key: 13714860 · Received March 9, 2022

    Report

    Report Number
    3004105610-2022-00022
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    February 15, 2022
    Report Date
    May 13, 2022
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A MIG, TOTAL HUMERAL REPLACEMENT WAS REPORTED. THE EVENT WAS CONFIRMED BY X RAY REVIEW. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. CLINICIAN REVIEW: THE IMPLANT IN SITU WAS FOR MIG TOTAL HUMERAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2017. THE SURGEON REPORTED MUSCLE CONTRACTURE, JOINT LUXATION, BW SHOULDER, FLEXI ELBOW. THE CT IMAGE PROVIDED SHOWS THAT THE HEMI SHOULDER HAD SUBLUXATION SUPERIORLY AND LATERALLY. THE ELBOW JOINT WAS SLIGHTLY IN FLEXION, WHICH MIGHT BE CAUSED BY MUSCLE CONTRACTION BUT CANNOT BE CONFIRMED. THEREFORE, THE RADIOGRAPHIC REVIEW CAN SUPPORT SOME OF THE CLINICAL REPORTS AND REASONS 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.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT PRESCRIPTION FORM WAS RECEIVED FOR THE PATIENT'S RIGHT TOTAL SHOULDER REPLACEMENT. NOTED ON THE FORM: "MUSCLE CONTRACTURE, JOINT LUXATION. BW SHOULDER, FLEXI ELBOW." PROPOSED DATE OF SURGERY IS BLANK. ADDITIONAL INFORMATION PROVIDED BY THE REP: "THE PATIENT HAS AN ELBOW MUSCLE CONTRACTURE AND HUMERAL JOINT LUXATION, RETRACTION DIDN'T HELP."

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT PRESCRIPTION FORM WAS RECEIVED FOR THE PATIENT'S RIGHT TOTAL SHOULDER REPLACEMENT. NOTED ON THE FORM: "MUSCLE CONTRACTURE, JOINT LUXATION. BW SHOULDER, FLEXI ELBOW." PROPOSED DATE OF SURGERY IS BLANK. ADDITIONAL INFORMATION PROVIDED BY THE REP: "THE PATIENT HAS AN ELBOW MUSCLE CONTRACTURE AND HUMERAL JOINT LUXATION, RETRACTION DIDN'T HELP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633074 TOTAL HUMERAL REPLACEMENT MINIMALLY INVASIVE GROWER (MIG) PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS STANMORE IMPLANTS WORLDWIDE PIN 20573

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention| H