BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 21183999 · Received January 17, 2025

    Report

    Report Number
    3005180920-2024-01164
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713191
    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 19-12-2024 LOT 2003783: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-10-2020. EXPIRATION DATE: 2025-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE DECENTER (K170910) LOT 2114001: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-01-2022. EXPIRATION DATE: 2026-12-09. 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

    AT ABOUT 1 YEAR AND 11 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THE HUMERAL HEAD DISASSOCIATING FROM THE DOUBLE CENTER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND DOUBLE DECENTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908075 ANATOMIC SHOULDER PROSTHESIS ANATOMICAL SHOULDER SYSTEM 04.01.0096 METAL HUMERAL HEAD Ø52 KWS MEDACTA INTERNATIONAL SA 04.01.0096 2003783 07630040713191

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention