BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM

    MDR report key: 11154583 · Received January 12, 2021

    Report

    Report Number
    3005180920-2021-00036
    Event Type
    Injury
    Date Received
    January 12, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LOT 1908971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT 2001142: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2020. EXPIRATION DATE: 2025-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    POTENTIALLY INFECTED EVENT, SUPPURATED WOUND 2 MONTHS AFTER PRIMARY. DURING THE SURGERY, THE SURGEON REALIZED THAT THE IMAGE OF LIQUID THAT WAS SEEN IN THE RESONANCE WAS ONLY A COLLECTION OF NON-PURULENT EXUDATE. AFTER A THOROUGH CLEANING, HOWEVER, HE DECIDED TO REPLACE GLENOSPHERE AND LINER WITH ITEMS OF THE SAME SIZE AND TO WASH ABUNDANTLY WITH DISINFECTANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51927 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+0MM SHUOLDER REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 1908971 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention