BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 19406105 · Received May 28, 2024

    Report

    Report Number
    3005180920-2024-00344
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    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 06 MAY 2024. LOT 2104819: 90 ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2021. EXPIRATION DATE: 2026-06-01. 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 REVISED: REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39X27 (K193175) LOT 2008831A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2021. EXPIRATION DATE: 2026-07-07. 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 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 2004032: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2021. EXPIRATION DATE: 2026-05-20. 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. REVERSE SHOULDER SYSTEM 04.01.0185 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12 (K180089) LOT 2105371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2021. EXPIRATION DATE: 2026-05-30. 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 04.01.0192 THREADED GLENOID BASEPLATE 27X30 (K171058) LOT 1906801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-11. 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 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624023 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER REVERSE LINER PHX MEDACTA INTERNATIONAL SA 2104819

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention