BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 24494897 · Received March 3, 2026

    Report

    Report Number
    3005180920-2026-00151
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 3, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 11 FEBRUARY 2026: REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER D 39/+0MM (K170452) LOT 2408547: 89 ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2024. EXPIRATION DATE: 2029-MAY-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 87 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XD 24.5 (K193175) LOT 2406385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2024. EXPIRATION DATE: 2029-JUN-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0400 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 10° (K231911) LOT 2315758: 33 ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2024. EXPIRATION DATE: 2029-JUN-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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 A LUXATION OF THE GLENOSPHERE AND THE LINER. THE CAUSE OF DISLOCATION IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY THE SURGEON REVISED THE LINER TO A CONSTRAINED LINER WHILE ALSO INCREASING THE SIZE FROM A D 39/+0 TO D 39/+3. THE SURGEON OBSERVED THAT ALL IMPLANTS WERE WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558419 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0122 2408547 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention