BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM

    MDR report key: 14885611 · Received July 1, 2022

    Report

    Report Number
    3005180920-2022-00502
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    June 10, 2022
    Report Date
    July 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706285
    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 17 JUNE 2022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2021. EXPIRATION DATE: 2026-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION 1 MONTH AFTER RSA DUE TO DISLOCATION OF THE HUMERAL IMPLANT FROM THE GLENOSPHERE. THE COMPONENTS REMAINED INTACT AND WE CANNOT DETECT ANY HINT OF A DEFECT THAT LED TO THE PROBLEM. THESE EVENTS ARE NORMALLY ORIGINATED BY INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. THEREFORE, THE SURGEON DECIDED TO REVISED THE IMPLANTS WITH BIGGER SIZES IMPLANTS IN ORDER TO GIVE MORE TENSION TO THE SOFT TISSUES. NO REASON TO SUSPECT FAULTY IMPLANTS. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 17 JUNE 2022 REVERSE SHOULDER SYSTEM 04.01.0172 GLENOSPHERE 36XØ27 (K170452) LOT. 2101362 LOT. 2101362: 100 ITEMS MANUFACTURED AND RELEASED ON 09-JUNE-2021. EXPIRATION DATE: 2026-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 44 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT RETURNED FOR THE CONTROL RX WITH NO PAIN OR SYMPTOMS. DISLOCATION OF THE LINER FROM THE GLENOSPHERE WAS DETECTED ONLY AFTER X-RAYS. THE REVISION SURGERY WAS PERFORMED AND THE SURGEON REVISED SUCCESSFULLY THE GLENOSPHERE AND INSERT (Ø36 TO Ø39).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207100 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM HUMERAL REVERSE LINER PHX MEDACTA INTERNATIONAL SA 04.01.0121 2112130 07630040706285

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention