BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24871717 · Received April 14, 2026

    Report

    Report Number
    3005180920-2026-00292
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728065
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 MARCH 2026. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XD 24.5 (K193175) LOT 2518004: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JAN-2025. EXPIRATION DATE: 17-SEP-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 04.01.0148 GLENOID BASEPLATE - D 22X15 (K1704529) LOT 2411808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEP-2024. EXPIRATION DATE: 30-JUL-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. X-RAYS EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT REVISION ABOUT 2 MONTHS AFTER PRIMARY DUE TO THE GLENOSPHERE DISSOCIATION FROM THE BASEPLATE AFTER LIFTING AN HEAVY OBJECT. ACCORDING TO REPORT, THE ADVERSE EVENT WAS MOST LIKELY CAUSED BY IMPLANTATION OF A MISMATCHED GLENOSPHERE AND GLENOID BASEPLATE AT THE PRIMARY SURGERY, PREVENTING PROPER TAPER ENGAGEMENT AT THE GLENOSPHERE-BASEPLATE INTERFACE. THEREFORE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. R&D ANALYSIS BASED ON THE PROVIDED INFORMATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED GLENOSPHERE DISSOCIATION WAS MOST LIKELY CAUSED BY IMPLANTATION OF A MISMATCHED GLENOSPHERE (SIZE 36XD 24.5) AND GLENOID BASEPLATE (D 22X15) AT THE PRIMARY SURGERY, PREVENTING PROPER TAPER ENGAGEMENT AT THE GLENOSPHERE-BASEPLATE INTERFACE. THIS IS FURTHER SUPPORTED BY THE FACT THAT THE BASEPLATE WAS WELL FIXED IN THE BONE, AND THEREFORE WAS NOT REVISED, AND THE GLENOSPHERE SCREW WAS REPORTED AS UNSCREWED RATHER THAN BROKEN. ROOT CAUSE:THE EVENT IS LIKELY THE RESULT OF THE UNINTENDED IMPLANTATION OF AN INCORRECT IMPLANT COMBINATION. 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

    THE PATIENT CAME IN PRESENTING PAIN AFTER LIFTING A HEAVY OBJECT. X-RAYS REVEALED THAT THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A REVISION SURGERY.DURING THE REVISION, IT WAS NOTED THAT THE INCORRECT SIZE COMBINATION WAS IMPLANTED AT THE PRIMARY SURGERY (GLENOSPHERE 24.5 WITH GLENOID BASEPLATE 22). IT IS UNCLEAR HOW THE ERROR WAS NOT NOTICED OR AVOIDED. THE ERROR WAS ONLY NOTED DURING THE REVISION SURGERY. THE SURGEON REVISED THE METAPHYSIS FROM A +0MM/0°; TO A +9MM/0°; SIZE, REVISED THE CONSTRAINED LINER TO A SAME SIZE NON-CONSTRAINED LINER, AND REVISED THE 36XD 24.5 GLENOSPHERE TO A SIZE D 36X22 GLENOSPHERE TO PROVIDE STABILITY WITH THE D 22X15 BASEPLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371030 SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5 HSD MEDACTA INTERNATIONAL SA 04.01.0207 2518004 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention