BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17259171 · Received July 5, 2023

    Report

    Report Number
    3005180920-2023-00498
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 5, 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 (B)(6) 2023 LOT 2213748: 50 ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2022. EXPIRATION DATE: 2027-10-18. 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 COMPONENTS INVOLVED IN THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT. 2217120: : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2022. EXPIRATION DATE: 2027-09-15. 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 04.01.0184 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 11 (K180089) LOT. 2211938: 5 ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2022. EXPIRATION DATE: 2027-06-21. 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.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. IT HAS BEEN REPORTED THAT THE STEM WAS UNDERSIZED. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS, DIAPHYSIS, AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418904 REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° SHOULDER REVERSE METAPHYSIS PHX MEDACTA INTERNATIONAL SA 04.01.0110 2213748 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention