BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23424406 · Received October 30, 2025

    Report

    Report Number
    3005180920-2025-01030
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2025. REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2502258: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2025. EXPIRATION DATE: 01-APR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE - Ø27X15 (K170452) LOT 2429838: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2025. EXPIRATION DATE: 13-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 54 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE - Ø39X27 (K170452) LOT 2432579: 60 ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2025. EXPIRATION DATE: 09-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2403075: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2024. EXPIRATION DATE: 27-FEB-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2416397: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 16- JUL-2024. EXPIRATION DATE: 03- JUL-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT 2503071: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2025. EXPIRATION DATE: 09-MAR-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO DEVICES OF THE SAME LOT INVOLVED IN THE COMPLAINT. REVERSE SHOULDER SYSTEM 04.01.0007 STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 12 (K170452) LOT 2424860: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2024. EXPIRATION DATE: 26-SEP-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2430412: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2025. EXPIRATION DATE: 19-FEB-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) 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.

    Description of Event or Problem · 0

    ON (B)(6) 2025 PRIMARY SURGERY WAS PERFORMED. ON (B)(6) 2025 1ST REVISION SURGERY DUE TO IMPLANT DISLOCATION (SUSPECTED FALL) LINER REVISED. ON (B)(6) 2025 2ND REVISION SHOULDER SURGERY ON THE LEFT SIDE DUE TO INFECTION. EXPLANTATION OF ALL COMPONENTS AND IMPLEMENTATION OF A COMPETITION SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251821 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2502258 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention