BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19088254 · Received April 11, 2024

    Report

    Report Number
    3005180920-2024-00208
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-MAR-2024 LOT 2207928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2022. EXPIRATION DATE: 2027-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 20-MAR-2024 REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2201877 LOT 2201877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2022. EXPIRATION DATE: 2027-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XØ24.5 (K193175) LOT. 2212982 LOT 2212982: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 2027-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    AFTER HAVE SENT THE INITIAL REPORT ON (B)(6) 2024 THE BRANCH CONFIRMED THE REVISION DATE IS (B)(6) 2024. THE DATE OF THE EVENT, THE EVENT DESCRIPTION AND THE DATE OF THE REVISION SURGERY WAS CHANGED.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING SHOULDER PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER, GLENOSPHERE, AND METAPHYSIS. NO ISSUES HAVE BEEN DETECTED WITH THE IMPLANTS.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING SHOULDER PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER, GLENOSPHERE, AND METAPHYSIS. NO ISSUES HAVE BEEN DETECTED WITH THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580887 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° SHOULDER HUMERAL METAPHYSIS PHX MEDACTA INTERNATIONAL SA 2207928 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention