BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15860281 · Received November 24, 2022

    Report

    Report Number
    3005180920-2022-00902
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 2203309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-04-07. 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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022: REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2212985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-07-19. 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. REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT 2202582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-03-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 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 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION. DURING THE SURGERY, IT WAS NOTICED THAT THE SHORT STEM WAS A LITTLE LOOSE DUE TO POOR BONE QUALITY. THE SURGEON REVISED SUCCESSFULLY THE STEM, METAPHYSIS, LINER AND GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918865 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM SHOULDER HUMERAL LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 2203309 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention