BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21888365 · Received April 23, 2025

    Report

    Report Number
    3005180920-2025-00296
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    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 26-03-2025. LOT 2348689: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-03-2024. EXPIRATION DATE: 2029-03-12. 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D DEPARTMENT. THE LINER DISSOCIATED FROM THE REVERSE METAPHYSIS DUE TO FAILURE OF THE COUPLING BETWEEN THE TWO COMPONENTS. GIVN THE INFORMATION AT HAND TI IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE. ADDITIONAL IMPLANTS INVOLVED BATCH REVIEW PERFORMED ON 26-03-2025 ON REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2414237 LOT 2414237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-09-2024. EXPIRATION DATE: 2029-09-02. 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. BATCH REVIEW PERFORMED ON 26-03-2025 ON REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10 (K231911) LOT. 2315761 LOT 2315761: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-07-2024. EXPIRATION DATE: 2029-06-23. 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. BATCH REVIEW PERFORMED ON 26-03-2025 ON REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5 (K193175) LOT. 2404990 LOT 2404990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-06-2024. EXPIRATION DATE: 2029-05-27. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. DURING THE SURGERY, THE SURGEON NOTICED THAT THE LINER HAD DISSOCIATED FROM THE METAPHYSIS. THE SURGEON UPSIZED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPORTED THAT HE ENCOUNTERED NO ISSUE DURING THE FIRST REVISION WITH THE COULPLING OF THE LINER, WHICH WAS IMPLANTED WITH 145° INCLINATION. PATIENT WAS A MUSCULAR ONE. ADDITIONALLY, REVIEWING THE DETAILS OF THE PRIMARY SURGERY IT WAS NOTICED THAT A NOT CLEARED COMBINATION OF IMPLANTS WAS USED, NAMELY: GRS BASEPLATE - FULL WEDGE 10 WITH LAT. GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727479 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2348689 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention