BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22911272 · Received August 28, 2025

    Report

    Report Number
    3005180920-2025-00815
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 28, 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 08 AUGUST 2025 ANATOMICAL SHOULDER SYSTEM 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT. 1906554: 12 ITEMS MANUFACTURED AND RELEASED ON 11 SEPT 2019. EXPIRATION DATE: 28 AUGUST 2024. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES ALSO REVISED: ANATOMICAL SHOULDER SYSTEM 04.01.0039 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 128° - 11 (K170910) LOT. 1710050: 80 ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2018. EXPIRATION DATE: 13 MAY 2023. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, 17 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. 1905791: 108 ITEMS MANUFACTURED AND RELEASED ON 22 OCT 2019. EXPIRATION DATE: 07 OCT 2024. NO ANOMALIES WERE 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. ANATOMICAL SHOULDER SYSTEM 04.01.0093 METAL HUMERAL HEAD Ø46 (K170910) LOT. 1908187: 52 ITEMS MANUFACTURED AND RELEASED ON 12 FEB 2020. EXPIRATION DATE: 02 FEB 2020. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, 49 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0131 HC PEGGED GLENOID Ø46 (K170910) LOT. 184443: 53 ITEMS MANUFACTURED AND RELEASED ON 12 FEB 2020. EXPIRATION DATE: 27 JAN 2024. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AFTER 4 YEARS AND 11 YEARS, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834104 SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 KWS MEDACTA INTERNATIONAL SA 04.01.0184 1906554 07630040715928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention