BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16618192 · Received March 27, 2023

    Report

    Report Number
    3005180920-2023-00178
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 27, 2023
    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 21-MAR-2023 LOT 2109617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2021. EXPIRATION DATE: 2026-09-08. 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. ADDITIONAL COMPONENT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2005603: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2020. EXPIRATION DATE: 2025-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED THAT THE PATIENT WAS DISLOCATING DURING EXTERNAL ROTATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE GLENOSPHERE, LINER, AND METAPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933910 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 2109617 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention