BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 25148957 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00448
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040712644
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2026 ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135 & DEG: -9 LOT. (K170910) LOT: 1905776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-11-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0093 METAL HUMERAL HEAD D 46 (K170910) LOT: 1905793: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2019. EXPIRATION DATE: 2024-10-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0131 HC PEGGED GLENOID D 46 (K170910) LOT: 182675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT: 1905791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2019. EXPIRATION DATE: 2024-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. 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.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PERSISTENT PAIN AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA OR BONE QUALITY ISSUES. THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER SYSTEM, LEAVING THE DIAPHYSIS IMPLANTED FROM THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174019 ANATOMIC SHOULDER PROSTHESIS HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-9 KWS MEDACTA INTERNATIONAL SA 04.01.0026 1905776 07630040712644

    Patients

    Seq Age Sex Outcome Treatment
    1