BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 14801073 · Received June 24, 2022

    Report

    Report Number
    3005180920-2022-00485
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 1910952B: 5 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-NOV-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ORIGINAL LOT 1910952: 113 ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2020. EXPIRATION DATE: 2025-MAY-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 103 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: PARTIAL REVISION 1 MONTH AFTER RSA DUE TO JOINT DISLOCATION. THE REASON OF THE ADVERSE EVENT IS UNKNOWN. LINER WAS REVISED MAINTAINING THE SAME THICKNESS OF THE LINER (+6MM) BUT CHANGING THE CCD ANGLE AT 155° IN ORDER TO HAVE MORE STABILITY. IT MAY BE POSSIBLE THAT THE DISLOCATION OCCURED DUE TO LAXITY OF THE SOFT TISSUES. WE DO NOT SEE ANY REASON TO SUSPECT A FAULTY DEVICE. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022: REVERSE SHOULDER SYSTEM 04.01.0121 HUMERAL REVERSE HC LINER Ø36/+6MM (K170452) LOT 2104818: 26 ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2021. EXPIRATION DATE: 2026-JUN-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO JOINT LUXATION 1 MONTH AFTER THE PRIMARY SURGERY. ONLY REPLACED INSERT WITH SAME THICKNESS BUT 155° BECAUSE THE ARTICULATION REMAINED VERY STABLE ONCE REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055678 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0169 1910952B 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention