BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 25077214 · Received May 5, 2026

    Report

    Report Number
    3005180920-2026-00376
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 5, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 APRIL 2026 REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER D 36/+0MM (K170452) LOT. 2409939: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2024. EXPIRATION DATE: 2029-MAY-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XD 24.5 (K193175) LOT. 2348684: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2024. EXPIRATION DATE: 2029-APR-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0301 GRS BASEPLATE - D 24.5X20 +3MM (K213459) LOT. 2308514: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2024. EXPIRATION DATE: 2029-APR-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. HOWEVER, THE FINDINGS ARE CONSISTENT WITH A LOCAL ALLERGIC REACTION. THERE IS NO INDICATION THAT A DEVICE-RELATED ISSUE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING-RELATED ISSUES.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO NICKEL ALLERGY AFTER ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE GLENOSPHERE TO A SENSITIN GLENOSPHERE AND THE INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219425 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0119 2409939 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1