BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 23180254 · Received September 30, 2025

    Report

    Report Number
    3005180920-2025-00892
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 SEPT 2025. REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM (K170452) LOT. 2434187: 45 ITEMS MANUFACTURED AND RELEASED ON 17-MARCH-2025. EXPIRATION DATE: 02-MARCH-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0230 LONG HUMERAL DIAPHYSIS - L200 - 12 (K192967) LOT 2310275: 35 ITEMS MANUFACTURED AND RELEASED ON 27-JULY-2023. EXPIRATION DATE: 2028-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 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 REVISION SURGERY AFTER 18 DAYS FROM THE PREVIOUS OPERATION DUE TO DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE PATIENT HAD PRIMARY SURGERY SHOULDER WITH COMPETITOR PRODUCTS AND THEN A REVISION WITH MEDACTA HUMERUS AND LINER WHILE THE GLENOSPHERE REMAINS OF THE COMPETITOR. FROM THE RADIOGRAPHIC IMAGE A FRACTURE IS VISIBLE BUT NO INFO IS GIVEN REGARDING THIS EVENT. THESE DISLOCATIONS 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. 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 PATIENT HAD PRIMARY SURGERY SHOULDER WITH COMPETITOR PRODUCTS. A REVISION WAS COMPLETED ON (B)(6) 2025, WHERE THE METAPHYSIS, LINER, AND DIAPHYSIS WERE REVISED. 18 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE LINER FROM THE COMPETITOR GLENOSPHERE AND A DIAPHYSIS FRACTURE (VISIBLE FROM THE X-RAYS), THE CAUSE OF WHICH REMAINED UNKNOWN. THE SURGEON REVISED THE MEDACTA LINER AND THE COMPETITOR GLENOSPHERE AND BASEPLATE. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106109 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM PHX MEDACTA INTERNATIONAL SA 04.01.0124 2434187

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention