BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

    MDR report key: 12779042 · Received November 9, 2021

    Report

    Report Number
    3005180920-2021-00867
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715478
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 OCTOBER.2021. LOT 1904749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-DEC-2019. EXPIRATION DATE: 2024-NOV-24. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED. REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5 (K193175) LOT. 2103688. LOT 2103688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-DEC-2019. EXPIRATION DATE: 2024-NOV-24. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT. 2103783. LOT 2103783: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2021. EXPIRATION DATE: 2026-MAY-06. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS (2 PIECES OF THIS LOT REPORTED IN THIS COMPLAINT). REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT. 2010016. LOT 2010016: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2020. EXPIRATION DATE: 2025-NOV-18. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS. REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT. 2006965. LOT 2006965: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2020. EXPIRATION DATE: 2025-AUG-19. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS. REVERSE SHOULDER SYSTEM 04.01.0007 STD HUMERAL DIAPHYSIS - CEMENTLESS - 12 (K170452) LOT. 2006061. LOT 2006061: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2020. EXPIRATION DATE: 2025-OCT-08. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003795. LOT 2003795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-NOV-26. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS. REVERSE SHOULDER SYSTEM 04.01.0127 HUMERAL REVERSE HC LINER Ø42/+6MM (K170452) LOT. 189839 LOT 189839: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2019. EXPIRATION DATE: 2024-JAN-13. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. SUBSEQUENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HUMERUS FROM THE GLENOSPHERE. THE SURGEON REVISED THE BASEPLATE, LATERALIZED GLENOSPHERE, HUMERAL DIAPHYSIS, REVERSE METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675610 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30 REVERSE SHOULDER GLENOID PHX MEDACTA INTERNATIONAL SA 04.01.0191 1904749 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention