BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23510667 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01081
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706278
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 OCTOBER 2025 REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER D 36/+3MM (K170452) LOT 2419700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2024. EXPIRATION DATE: 19-SEP-2029. 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 04.01.0169 GLENOSPHERE - D 36X24.5 (K170452) LOT 2505179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2025. EXPIRATION DATE: 15-APR-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. REVERSE SHOULDER SYSTEM 04.01.0402 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 20° (K231911) LOT 2339032: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-AUG-2024. EXPIRATION DATE: 29-JUN-2029. 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 AFTER 1 MONTH FROM THE PRIMARY DUE TO DISLOCATION OF THE LINER FROM THE GLENOSPHERE. ACCORDING TO REPORT THIS WAS CAUSED BY A FALL. THE COMPONENTS REMAINED INTACT AND WE CANNOT DETECT ANY HINT OF A DEFECT THAT LED TO THE PROBLEM. THESE EVENTS ARE NORMAL ORIGINATED BY INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND. ADDITTIONAL INFORMATION REGARDING THE SURGERY: THE SURGEON REVISED THE LINER, GLENOSPHERE, METAPHYSIS, AND DIAPHYSIS. THE DIAPHYSIS WAS REVISED BECAUSE THE SURGEON BELIEVED THE BASEPLATE MAY HAVE BEEN POSITIONED TOO ANTEVERTED DURING THE PRIMARY PROCEDURE. SINCE IT WAS A GRS BASEPLATE, HE PREFERRED NOT TO MANIPULATE IT AND INSTEAD DECIDED TO REPOSITION THE STEM TO COMPENSATE FOR THE BASEPLATE & RSQUO; S ANTEVERSION. THE FALL WAS NOT THE CAUSE OF THE BASEPLATE ANTEVERSION. THE PATIENT HAD AN ANTIBIOTIC SPACER DUE TO AN INFECTION AND A PREVIOUS COMPETITOR TSA. AS A RESULT, HIS GLENOID WAS SEVERELY ERODED. THE SURGERY WAS COMPLETED SUCCESSFULLY. ROOT CAUSE: THE ISSUE MAY HAVE RELATED TO THE SPECIFIC PARAMETERS OF THE INITIAL SURGERY, BUT THIS CANNOT BE CONFIRMED. 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 POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AFTER 1 MONTH FROM THE PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION OF THE LINER FROM THE GLENOSPHERE THAT WAS CAUSED BY A FALL. THE SURGEON REVISED THE LINER, GLENOSPHERE, METAPHYSIS, AND DIAPHYSIS. THE DIAPHYSIS WAS REVISED BECAUSE THE SURGEON BELIEVED THE BASEPLATE MAY HAVE BEEN POSITIONED TOO ANTEVERTED DURING THE PRIMARY PROCEDURE. SINCE IT WAS A GRS BASEPLATE, HE PREFERRED NOT TO MANIPULATE IT AND INSTEAD DECIDED TO REPOSITION THE STEM TO COMPENSATE FOR THE BASEPLATE & RSQUO; S ANTEVERSION. THE FALL WAS NOT THE CAUSE OF THE BASEPLATE ANTEVERSION. THE PATIENT HAD AN ANTIBIOTIC SPACER DUE TO AN INFECTION AND A PREVIOUS COMPETITOR TSA. AS A RESULT, HIS GLENOID WAS SEVERELY ERODED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616119 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0120 2419700 07630040706278

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention