BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23583095 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01145
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 NOV 2025. REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER D 39/+3MM (K170452) LOT. 2243890: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 FEB 2023. EXPIRATION DATE: 22 JAN 2028. 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 04.01.0279 SENSITIN LAT. GLENOSPHERE 39XD 24.5 (K203755) LOT. 2503233: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 JULY 2025. EXPIRATION DATE: 07 JULY 2030. 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. CLINICAL EVALUATION: REVISION SURGERY 1 MONTH AFTER THE PRIMARY SURGERY, DUE TO A DISLOCATION. THESE EVENTS ARE NORMALLY ORIGINATED BY INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. ROOT CAUSE: ALTHOUGH A PRECISE ROOT CAUSE CANNOT BE ESTABLISHED, THESE EVENTS ARE GENERALLY RELATED TO INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER SURGERY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY MANUFACTURING-RELATED ISSUE.

    Description of Event or Problem · 0

    AFTER 1 MONTH FROM THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO A DISLOCATION, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, BASEPLATE, LINER, AND LOCKING SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236429 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2243890 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention