BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21157356 · Received January 15, 2025

    Report

    Report Number
    3005180920-2024-01130
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 15, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040715928
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6)2024. LOT 2240254: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2022. EXPIRATION DATE: 2027-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT. REVISION ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY TSA, DUE TO STEM BREACHING THE CORTEX. THE STEM WAS FOUND TO BE WELL FIXED. HOWEVER, IN ORDER TO ALLEVIATE THE PAIN, THE SURGEON DECIDED TO REMOVE ALL COMPONENTS AND CONVERTED THE PATIENT FROM A PRIMARY TO A REVERSE SHOULDER WITH A STANDARD STEM. FROM THE POST-OP PRIMARY RADIOGRAPHIC IMAGE, THE STEM APPEARS TO BE IN A SUBOPTIMAL POSITION. WE CANNOT TELL IF THIS IS THE RESULT OF POST-SURGERY MIGRATION OR IF IT WAS THE POSITION SINCE THE CONCLUSION OF THE PRIMARY SURGERY. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.- BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO STEM BREACHING THE LATERAL CORTEX. THE STEM WAS FOUND TO BE WELL FIXED. HOWEVER, IN ORDER TO ALLEVIATE THE PAIN, THE SURGEON REMOVED ALL THE COMPONENTS AND CONVERTED THE PATIENT FROM A PRIMARY TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363870 SHOULDER SYSTEM ANATOMICAL SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 KWS MEDACTA INTERNATIONAL SA 04.01.0184 2240254 07630040715928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention