BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22291440 · Received June 19, 2025

    Report

    Report Number
    3005180920-2025-00572
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    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 04 JUNE 2025. LOT 2217813: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-11-2022 EXPIRATION DATE: 2027-11-02. 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. ADDITIONAL COMPONENTS INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 04 JUNE 2025 REVERSE SHOULDER SYSTEM 04.01.0006 STD HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K170910) LOT 2209901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-06-2022 EXPIRATION DATE: 2027-06-10. 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. BATCH REVIEW PERFORMED ON 04 JUNE 2025 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2240209: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-02-2023 EXPIRATION DATE: 2028-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 79 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 04 JUNE 2025 REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT 2000926: 26 ITEMS MANUFACTURED AND RELEASED ON 16-04-2020 EXPIRATION DATE: 2025-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 04 JUNE 2025 REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2240585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-12-2022 EXPIRATION DATE: 2027-11-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 32 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

    AT ABOUT 2 YEARS AND 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496820 SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15 PHX MEDACTA INTERNATIONAL SA 04.01.0154 2217813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention