BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23309927 · Received October 16, 2025

    Report

    Report Number
    3005180920-2025-00994
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715478
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 OCTOBER 2025: REVERSE SHOULDER SYSTEM 04.01.0191 THREADED GLENOID BASEPLATE Ø24.5X30 (K171058) LOT 2116430: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2022. EXPIRATION DATE: 2027-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) 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 2244671: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2023. EXPIRATION DATE: 2028-01-03. 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 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT 2240232: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 2027-11-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0182 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 9 (K180089) LOT 2241413: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2023. EXPIRATION DATE: 2027-11-27. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: A REVISION SURGERY WAS PERFORMED APPROXIMATELY TWO AND A HALF YEARS AFTER THE IMPLANTATION OF A RSA, DUE TO PAIN CAUSED BY GLENOID COMPONENT LOOSENING. THE AVAILABLE X-RAY IMAGE CLEARLY SHOWS MOBILIZATION OF THE BASEPLATE, WHICH APPEARS TO HAVE MIGRATED CRANIALLY, AS WELL AS RADIOLUCENT LINES AROUND THE DISTAL SCREW AND A FRACTURED PROXIMAL SCREW. THE SCREW BREAKAGE WAS MOST LIKELY CAUSED BY MICROMOTION OF THE LOOSENED GLENOID CONSTRUCT, RESULTING IN ABNORMAL AND INCONGRUOUS STRESS ON THE AFFECTED SCREW. GIVEN THE DIFFICULTY OF RETRIEVING THE BROKEN FRAGMENT AND CONSIDERING THAT THE MATERIAL IS SUITABLE FOR LONG-TERM IMPLANTATION, THE SURGEON UNDERSTANDABLY DECIDED TO LEAVE IT IN SITU. THE PRECISE CAUSE OF THE GLENOID LOOSENING CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IN GENERAL, ASEPTIC LOOSENING OF THE GLENOID COMPONENT IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE, OFTEN OF MULTIFACTORIAL OR UNCLEAR ETIOLOGY. ADDITIONALLY, BONE RAREFACTION WAS OBSERVED IN THE HUMERUS AROUND THE STEM, PARTICULARLY IN THE METAPHYSEAL REGION. HOWEVER, THE STEM WAS NOT REVISED, AS THE SURGEON JUDGED IT TO BE SUFFICIENTLY STABLE. ROOT CAUSE: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY SHOULDER ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE. FOR THE SCREW BREAKAGE BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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 DIAPHYSIS SHOW RADIOLUCENT LINES THE SURGEON SAID IT WAS KIND OF LOOSE AND WAS CAUSING PAIN WHEN THE PATIENT MOVED. THE BASEPLATE IS LOOSE TOO. IN THE X-RAYS A BROKEN SCREW IS VISIBLE BUT THE REASON IS UNKNOWN. AT ABOUT 2 YEARS AND 4 MONTHS POST-PRIMARY THE SURGEON REVISED THE LINER AND METAPHYSIS WITH MEDACTA PRODUCT AND REVISED THE BASEPLATE WITH A COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665322 SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30 PHX MEDACTA INTERNATIONAL SA 04.01.0191 2116430 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention