BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21736862 · Received April 1, 2025

    Report

    Report Number
    3005180920-2025-00262
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-MAR-2025: LOT 2312760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-12-2023. EXPIRATION DATE: 2028-11-19. 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. ADDITONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 14-MAR-2025: REVERSE SHOULDER SYSTEM 04.01.0004 STANDARD HUMERAL DIAPHYSIS S9 (K170910) LOT 2207913: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-06-2022. EXPIRATION DATE: 2027-05-26. 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 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2346718: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-01-2024. EXPIRATION DATE: 2029-01-10. 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 LOT. 2347371 (K170452) LOT 2347371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-01-2024. EXPIRATION DATE: 2029-01-13. 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 04.01.0111 HUMERAL REVERSE METAPHYSIS +9MM/0° (K170452) LOT 2003393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-10-2020. EXPIRATION DATE: 2025-10-08. 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 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT 1909888: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-02-2020. EXPIRATION DATE: 2025-02-05. 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 04.01.0155 GLENOID BASEPLATE - Ø27X25 (K170452) LOT 2318878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-02-2024. EXPIRATION DATE: 2029-01-30. 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 04.01.0211 LAT. GLENOSPHERE 39XØ27 (K193175) LOT 2336629: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-01-2024. EXPIRATION DATE: 2029-01-01. 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: REVISION SURGERY 1 YEAR AFTER THE PREVIOUS OPERATION, REPORTEDLY DUE TO METAL ALLERGY AND SUSPECTED INFECTION BUT THERE IS NO MENTION OF CLINICAL CONDITIONS. THIS IS A SECOND REVISION, THE FIRST ONE WAS DUE TO INFECTION. FROM THE RADIOGRAPHIC IMAGES IT IS NOT POSSIBLE TO EVALUATE THIS CONDITION. THESE ARE KNOWN POSSIBLE ADVERSE EVENTS. THE REPORTED CAUSE WAS METAL ALLERGY WITH NO ALLEGED DEVICE DEFICIENCY OR CONTRIBUTING FACTOR, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    ON (B)(6)2023 PATIENT UNDERGONE REVERSE SHOULDER ARTHROPLASTY. ON THE (B)(6)2024 SURGEON REVISED AL COMPONENTS DUE TO INFECTION (MDR 3005180920-2024-00151). ON (B)(6) 2025 ALL COMPONENTS WERE REVISED FOR METAL ALLERGY ALONG WITH A SUSPICION OF INFECTION (METAL ALLERGY). NO LOOSENING OF THE COMPONENTS. SURGEON IMPLANTED COMPETITOR IPOALLERGENIC DEVICE AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912867 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0122 2312760 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention