BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46

    MDR report key: 17868939 · Received October 4, 2023

    Report

    Report Number
    3005180920-2023-00781
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713160
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 SEPTEMBER 2023: LOT 1903164: 20 ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2019. EXPIRATION DATE: 2024-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 14 SEPTEMBER 2023: ANATOMICAL SHOULDER SYSTEM 04.01.0004 STD HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K170452) LOT 2012131: 26 ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2021. EXPIRATION DATE: 2026-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0026 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 9 (K170910) LOT 1811227: 49 ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 43 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0130 HC PEGGED GLENOID Ø44 (K170910) LOT 2103247: 26 ITEMS MANUFACTURED AND RELEASED ON 30-APR-2021. EXPIRATION DATE: 2026-04-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT 2003985: 117 ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2021. EXPIRATION DATE: 2025-12-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 105 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 1 YEAR AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO NOT BEING ABLE TO HAVE FULL ARM ROTATION. RANGE OF MOTION WAS LIMITED AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105167 ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46 SHOULDER METAL HEAD KWS MEDACTA INTERNATIONAL SA 1903164 07630040713160

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention