BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM

    MDR report key: 15869313 · Received November 28, 2022

    Report

    Report Number
    3005180920-2022-00879
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    November 2, 2022
    Report Date
    November 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-NOV-2022: LOT 1908971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-OCT-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 2 YEARS AND 2 MONTHS AFTER THE SURGERY. THE PATIENT REPORTED PAIN. FROM RADIOGRAPHIC IMAGES, SCAPULAR NOTCHING IS OBSERVED IN THE DISTAL ASPECT OF THE BONE. THE SURGEON PERFORMED AN ARTHROTOMY WITH SOFT TISSUE/FLUID TESTING FOR INFECTION AND REVISED THE GLENOSPHERE WHICH WAS SUBSTITUTED WITH A LATERALIZED ONE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 1908252: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-MAR-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) LOT 183537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2018. EXPIRATION DATE: 2023-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN. SCAPULAR NOTCHING WAS OBSERVED ON X-RAYS. THE SURGEON PERFORMED AN ARTHROTOMY WITH SOFT TISSUE/FLUID TESTING FOR INFECTION AND REVISED THE GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852844 REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 1908971 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention