BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0°

    MDR report key: 18158144 · Received November 17, 2023

    Report

    Report Number
    3005180920-2023-00898
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    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 16-NOV-2023. LOT 2236620: (B)(4) MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-01-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0118 HUMERAL REVERSE HC LINER Ø32/+6MM (K170452) LOT 2203296: (B)(4) MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0206 LAT. GLENOSPHERE 32XØ24.5 (K193175) LOT 2117710: (B)(4) MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2027-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND DISCOMFORT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286925 REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° SHOULDER HUMERAL REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 2236620 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention