BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19890641 · Received August 2, 2024

    Report

    Report Number
    3005180920-2024-00640
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 2, 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 18-JUL-2024. LOT 2307537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 2028-07-24. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18-JUL-2024. REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT. 2103687 LOT 2103687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2021. EXPIRATION DATE: 2026-06-24. 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.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING TIGHTNESS. THE SURGEON REVISED THE LINER AND DECREASED LATERALIZATION BY REVISING THE LATERALIZED GLENOSPHERE TO A STANDARD GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863378 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 2307537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention