BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22573884 · Received July 23, 2025

    Report

    Report Number
    3005180920-2025-00720
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    May 13, 2025
    Report Date
    July 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706339
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JULY 2025 LOT 2240224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/01/2023. EXPIRATION DATE: 02/12/2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED AND REVISED: REVERSE SHOULDER SYSTEM 04.01.0174 GLENOSPHERE - Ø42X27 (K170452) LOT 2307388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17/05/2023. EXPIRATION DATE: 01/05/2028. 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. 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

    PRIMARY SURGERY PERFORMED ON (B)(6) 2025. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. ON (B)(6) 2025, A SECOND REVISION SURGERY WAS PERFORMED DUE TO JOINT LUXATION; THE LINER AND GLENOSPHERE WERE REVISED. THE GLENOSPHERE WAS CHANGED FROM 42MM STD TO 39MM/+3MM LAT AND THE LINER FROM 42MM/+3MM TO 39MM/+3MM. PATIENT HISTORY: PRIMARY SURGERY PERFORMED ON (B)(6) 2025. 1ST REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (B)(4). 2ND REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER AND GLENOSPHERE REVISED. (B)(4). 3RD REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO JOINT LUXATION; LINER, GLENOSPHERE, AND METAPHYSIS REVISED. (B)(4). 4TH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE JOINT LUXATION; PATIENT CONVERTED TO HEMIARTHROPLASTY - GLENOSPHERE AND BASEPLATE REMOVED, LINER AND METAPHYSIS REPLACED WITH ANATOMICAL COMPONENTS (B)(4). 5TH REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INTRA-PROSTHETIC DISLOCATION (METAL HUMERAL HEAD AND DOUBLE ECCENTER) - HUMERAL HEAD AND THE DOUBLE ECCENTRIC REVISED AND SURROUNDING BONE TRIMMED USING A RONGEUR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731539 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0126 2240224 07630040706339

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention