BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANATOMIC SHOULDER PROSTHESIS

    MDR report key: 23001781 · Received September 9, 2025

    Report

    Report Number
    3005180920-2025-00876
    Event Type
    Death
    Date Received
    September 9, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040706056
    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 25 AUGUST 2025: REVERSE SHOULDER SYSTEM 04.01.0006 STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K170910) LOT 2409955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUNE-2024. EXPIRATION DATE: 2029-05-26. 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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 25 AUGUST 2025: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2414237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2024. EXPIRATION DATE: 2029-09-02. 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. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2417516: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JULY-2024. EXPIRATION DATE: 2029-07-08. 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. REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 (K170452) LOT 2421551: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2024. EXPIRATION DATE: 2029-08-29. 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. REVERSE SHOULDER SYSTEM 04.01.0164 GLENOID POLYAXIAL LOCKING SCREW - L42 (K170452) LOT 2337218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2023. EXPIRATION DATE: 2028-11-11. 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. REVERSE SHOULDER SYSTEM 04.01.0127 HUMERAL REVERSE HC LINER Ø42/+6MM (K170452) LOT 2307538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 2028-07-18. 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. REVERSE SHOULDER SYSTEM 04.01.0174 GLENOSPHERE - Ø42X27 (K170452) LOT 1910956: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2020. EXPIRATION DATE: 2025-05-13. 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. MY SHOULDER 04.01.CM24.298 RECONSTRUCTION REVERSE GLENOID LOT 19311P: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. 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

    PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025 (B)(6) MEDICAL CENTER. ON (B)(6) 2025 REVISION SURGERY PERFORMED. THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND LANDING ON THE SHOULDER, LEADING TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED ONLY THE LINER (0 MM TO 6 MM). SOMETIME IN MID-(B)(6) 2025, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. NO ISSUE WITH MEDACTA DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068874 ANATOMIC SHOULDER PROSTHESIS STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 11 KWS MEDACTA INTERNATIONAL SA 04.01.0006 2409955 07630040706056

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death