BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ24.5

    MDR report key: 18648767 · Received February 6, 2024

    Report

    Report Number
    3005180920-2024-00031
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040708135
    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 23 JANUARY 2024 LOT 189863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2019. EXPIRATION DATE: 2024-02-26. 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 23 JANUARY 2024 REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT 2001979: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2020. EXPIRATION DATE: 2025-04-15. 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 23 JANUARY 2024 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2003769: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2021. EXPIRATION DATE: 2026-02-08. 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 23 JANUARY 2024 REVERSE SHOULDER SYSTEM 04.01.0116 HUMERAL REVERSE HC LINER Ø32/+0MM (K170452) LOT 183525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2018. EXPIRATION DATE: 2023-06-10. 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. BATCH REVIEW PERFORMED ON 23 JANUARY 2024 REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 2010121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2021. EXPIRATION DATE: 2025-12-15. 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. BATCH REVIEW PERFORMED ON 23 JANUARY 2024 REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2010934: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2021. EXPIRATION DATE: 2026-02-17. 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.

    Description of Event or Problem · 0

    AT 2 YEARS AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HUMERAL REVERSE LINER, HUMORAL REVERSE METAPHYSIS, GLENOSPHERE, PEGGED BASEPLATE AND TWO SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092405 REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ24.5 SHOULDER REVERSE GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 189863 07630040708135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention