BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21122215 · Received January 10, 2025

    Report

    Report Number
    3005180920-2024-01168
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630542714627
    PMA / PMN Number
    K231911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY EVALUATION PERFORMED BY R&D PROJECT MANAGER: AS PER PROVIDED INFORMATION, A LATERALIZED GLENOSPHERE WAS USED IN COMBINATION WITH A GRS FULL WEDGE BASEPLATE. AS REPORTED IN THE SURGICAL TECHNIQUE, THIS COUPLING IS NOT CLEARED AS IT LEADS TO HIGHER LEVER-ARM AND INCREASED RISK OF IMPLANT LOOSENING. THIS COUPLING IN COMBINATION WITH THE REPORTED POOR BONE QUALITY MAY HAVE LED TO IMPLANT MOBILIZATION. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION SURGERY WAS PERFORMED 1.5 MONTHS AFTER PRIMARY RSA DUE TO A LOOSE GLENOID BASEPLATE. BASED ON THE IMAGES PROVIDED, THE LOW QUALITY OF THE IMAGES MAKES IT IMPOSSIBLE TO ASSESS THE POSITION OF THE BASEPLATE. FOR THE PRIMARY PROCEDURE, THE GRS FULL WEDGE 10-DEGREE BASEPLATE AND THE LATERALIZED GLENOSPHERE WERE USED. THIS COUPLING CHALLENGES THE FIXATION OF THE IMPLANT TO THE BONE, PARTICULARLY IN CASES OF POOR BONE QUALITY. THE CHOICE MUST HAVE BEEN MADE BY THE SURGEON BASED ON ANATOMICAL AND BIOMECHANICAL CONSIDERATIONS BUT IT DIDN'T RESIST THE TEST OF REAL LIFE. BATCH REVIEW PERFORMED ON 30 DECEMBER 2024. REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10° (K231911) LOT 2315755: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2024. EXPIRATION DATE: 2029-APR-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452) LOT 2411138: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2024. EXPIRATION DATE: 2029-JUN-03. 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 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 2405923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2024. EXPIRATION DATE: 2029-APR-10. 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 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2409392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2024. EXPIRATION DATE: 2029-MAY-09. 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 (TWO DEVICES INVOLVED IN THE PRESENT CASE). AS REPORTED IN THE SURGICAL TECHNIQUE, THIS COUPLING IS NOT CLEARED AS IT LEADS TO HIGHER LEVER-ARM AND INCREASED RISK OF IMPLANT LOOSENING. THIS COUPLING IN COMBINATION WITH THE REPORTED POOR BONE QUALITY MAY HAVE LED TO IMPLANT MOBILIZATION.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE GLENOID BASEPLATE AND THE CAUSE IS UNKNOWN. ABOUT 1 MONTH AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE BASEPLATE, LINER, METAPHYSIS, GLENOSPHERE, AND SCREWS (METAPHYSIS WAS REMOVED TO ACCESS THE GLENOID COMPONENTS). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379955 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - Ø24.5X20 - FULL WEDGE 10° PHX MEDACTA INTERNATIONAL SA 04.01.0400 2315755 07630542714627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention