BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 22076618 · Received May 23, 2025

    Report

    Report Number
    3005180920-2025-00457
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713290
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MAY 2025: LOT 2011106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2021. EXPIRATION DATE: 2025-12-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT 2309089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2023. EXPIRATION DATE: 2028-06-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. AT 5 MONTHS FROM PRIMARY UPON REMOVING THE STEM, IT WAS VIEWED BY THE SURGEON THAT THE STEM WAS SITTING PROUD AND HAD A LOT OF OSTEOPHYTES UNDER THE ANATOMIC HEAD THAT DID NOT ALLOW THE STEM TO SIT CORRECTLY. THE SURGEON THEN DESCRIBED THAT THE VERSION, CUT ANGLE AND STEM DEPTH SEEMED TO BE INCORRECT. THE STEM WAS REMOVED. THE PEGGED GLENOID WAS FLOATING IN THE JOINT SPACE WITH CEMENT ON THE BACK OF IT. THE SURGEON MADE THE OBSERVATION THAT IT DID NOT APPEAR THAT THE GLENOID WAS EVER FULLY CEMENTED DOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221134 ANATOMIC SHOULDER PROSTHESIS ANATOMICAL SHOULDER SYSTEM 04.01.0134 HC PEGGED GLENOID Ø52 KWS MEDACTA INTERNATIONAL SA 04.01.0134 2011106 07630040713290

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention