BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21771468 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00276
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706186
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MARCH 2025: LOT 2114023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-02-28. 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. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 20 MARCH 2025: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT 2218469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2022. EXPIRATION DATE: 2027-09-19. 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 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT 2243585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2022. EXPIRATION DATE: 2027-11-30. 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 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058) LOT 2306948: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2023. EXPIRATION DATE: 2028-08-19. 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

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND LINER. THER SURGERY WAS COMPLETE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745082 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0111 2114023 07630040706186

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention