BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL HUMERUS (BAYLEY/WALKER) MIG

    MDR report key: 15143695 · Received August 2, 2022

    Report

    Report Number
    3004105610-2022-00123
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    July 12, 2022
    Report Date
    October 10, 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A MIG TOTAL HUMERAL REPLACEMENT (BAYLEY/WALKER) 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 (BAYLEY/WALKER), WHICH WAS INSERTED ON (B)(6) 2018. THE SURGEON REPORTED LUXATION RECURRENCE OF SHOULDER. THE CT IMAGE PROVIDED SHOWS THAT THE HUMERAL HEAD HAS SUBLUXED SUPERIORLY. 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.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT REQUEST FORM WAS RECEIVED FOR THE PATIENT'S LEFT HUMERAL MIG. NOTED ON THE FORM: "REPLACE THE PROXIMAL PART OF THE IMPLANT, SAVE THE (HEMI) ELBOW PART. BW TYPE IS REQUIRED. PATIENT DIAGNOSIS: LUXATION RECURRENCE."

    Description of Event or Problem · 0

    A PATIENT SPECIFIC IMPLANT REQUEST FORM WAS RECEIVED FOR THE PATIENT'S LEFT HUMERAL MIG. NOTED ON THE FORM: "REPLACE THE PROXIMAL PART OF THE IMPLANT, SAVE THE (HEMI) ELBOW PART. BW TYPE IS REQUIRED. PATIENT DIAGNOSIS: LUXATION RECURRENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359506 TOTAL HUMERUS (BAYLEY/WALKER) MIG PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS STANMORE IMPLANTS WORLDWIDE PIN 21576

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Required Intervention| H