BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20610065 · Received November 5, 2024

    Report

    Report Number
    3005180920-2024-00915
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 OCT 2024: LOT 2343406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2024. EXPIRATION DATE: 2029-01-29. 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 IMPLANTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM K170452 LOT. 2305691 BATCH REVIEW PERFORMED ON 15 OCT 2024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2023. EXPIRATION DATE: 2028-06-19. 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 04.01.0151 GLENOID BASEPLATE - Ø24.5X15 K170452 LOT. 2318865 BATCH REVIEW PERFORMED ON 15 OCT 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2024. EXPIRATION DATE: 2029-01-24. 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 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 K170452 LOT. 2339645: BATCH REVIEW PERFORMED ON 15 OCT 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2024. EXPIRATION DATE: 2029-01-29. 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 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 K170452 LOT. 2342412: BATCH REVIEW PERFORMED ON 15 OCT 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2024. EXPIRATION DATE: 2029-01-27. 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 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 K180089 LOT. 2344614. BATCH REVIEW PERFORMED ON 15 OCT 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JAN-2024. EXPIRATION DATE: 2029-01-02. 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 04.01.0206 LAT. GLENOSPHERE 32XØ24.5 K193175 LOT. 2103686 BATCH REVIEW PERFORMED ON 15 OCT 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-05-09. 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. ROOT CAUSE: 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 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48839 SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0 PHX MEDACTA INTERNATIONAL SA 04.01.0110 2343406 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention