BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23244046 · Received October 8, 2025

    Report

    Report Number
    3005180920-2025-00972
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 22 SEPT 2025: REVERSE SHOULDER SYSTEM 04.01.0111 HUMERAL REVERSE METAPHYSIS +9MM/0° (K170452) LOT. 2244281: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APRIL-2023. EXPIRATION DATE: 22-MARCH-2028. 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. REVERSE SHOULDER SYSTEM 04.01.0148 GLENOID BASEPLATE - Ø22X15 (K170452) LOT. 2217807: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2022. EXPIRATION DATE: 02-NOV-2027. 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. REVERSE SHOULDER SYSTEM 04.01.0167 GLENOSPHERE - Ø32X22 (K170452) LOT. 2109110: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 26-SEPT-2029. 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. REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM (K170452) LOT. 2240558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 01-DEC-2027. 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. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 2247096: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2023. EXPIRATION DATE: 27-JAN-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0199 GLENOID POLYAXIAL NON-LOCKING SCREW - L34 (K181826) LOT. 2240266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-NOV-2022. EXPIRATION DATE: 09-NOV-2027. NO ANOMALIES 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. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: - B5 DESCRIBE EVENT OR PROBLEM. - D6A IMPLANTED DATE.

    Description of Event or Problem · 0

    AFTER 2 YEARS AND 1 MONTH POST-PRIMARY, THE PATIENT CAME IN DUE TO INFECTION, AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND CONVERTED THE PATIENT TO AN ANATOMIC SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PRIMARY REVERSE SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2025, DUE TO INFECTION, THE SURGEON PERFORMED A WASHOUT AND TEMPORARILY CONVERTED THE SHOULDER TO AN ANATOMIC SYSTEM INSTEAD OF USING A SPACER. ON (B)(6) 2025, AFTER THE INFECTION CLEARED, THE PATIENT WAS REVISED BACK TO A REVERSE SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609996 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0111 2244281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention