BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0

    MDR report key: 12655740 · Received October 19, 2021

    Report

    Report Number
    3005180920-2021-00812
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706186
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2021: LOT 2001145: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AGO-2020. EXPIRATION DATE: 2025-AGO-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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 23 SEPTEMBER 2021: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 2100435: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-MAR-15. 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 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT 2004000: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2021. EXPIRATION DATE: 2026-MAR-10. 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 · 1

    THE PATIENT CAME IN REPORTING LATERAL INSTABILITY AND THE CAUSE OF THE INSTABILITY IS LAXITY. ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555050 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0 SHOULDER HUMERAL METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0111 2001145 07630040706186

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention