BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM

    MDR report key: 12983078 · Received December 13, 2021

    Report

    Report Number
    3005180920-2021-00975
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    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 09-DEC-2021. LOT 2004021: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2021. EXPIRATION DATE: 2026-APR-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003392. LOT 2006591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-OCT-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT. 1910851. LOT 1910851: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-MAR-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER AND STEM LOOSENING 2 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE LINER, METAPHYSIS AND DIAPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888226 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0120 2006591 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention