BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM

    MDR report key: 12040246 · Received June 22, 2021

    Report

    Report Number
    3005180920-2021-00503
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2021. LOT 2100433: 112 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-03-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2021. REVERSE SHOULDER SYSTEM 04.01.0007 STD HUMERAL DIAPHYSIS - CEMENTLESS - 12 (K170452) LOT. 1902896 LOT 1902896: 40 ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2019. EXPIRATION DATE: 2024-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 2003864A LOT 2003864A: 94 ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2020. EXPIRATION DATE: 2025-12-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD PRIMARY REVERSE SHOULDER SURGERY ON (B)(6) 2021. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY FOLLOWING DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND METAPHYSIS. PRESENTLY, 4 DAYS AFTER THE PREVIOUS SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE PATIENT'S HUMERUS WAS FRACTURED WHILE PERFORMING A REDUCTION. THE SURGEON REVISED ALL IMPLANTS AND REPAIRED THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936796 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM HUMERAL REVERSE HC LINER Ø36/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0120 2100433 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention