BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25

    MDR report key: 16680117 · Received April 5, 2023

    Report

    Report Number
    3005180920-2023-00210
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706421
    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 (B)(6) 2023: LOT 2006582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2020. EXPIRATION DATE: 2025-11-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 LOT. 2005661 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2020. EXPIRATION DATE: 2025-08-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 LOT. 2002443 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2020. EXPIRATION DATE: 2025-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0211 LAT. GLENOSPHERE 39XØ27 LOT. 189945 (K193175): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2019. EXPIRATION DATE: 2024-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. RESTERILIZED DEVICES OF THIS LOT CONSIDERED IN THIS BATCH. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 LOT. 2002440 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2020. EXPIRATION DATE: 2025-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. 2 DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° LOT. 2001815 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2020. EXPIRATION DATE: 2025-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 LOT. 2002440 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2020. EXPIRATION DATE: 2025-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. 2 DEVICES OF THIS LOT INVOLVED IN THIS COMPLAINT. REVERSE SHOULDER SYSTEM 04.01.0007 STD HUMERAL DIAPHYSIS - CEMENTLESS - 12 LOT. 1910843 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAR-2020. EXPIRATION DATE: 2025-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM LOT. 2006593 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2020. EXPIRATION DATE: 2025-10-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR INFECTION AT ABOUT 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGEON REVISED SUCCESSFULLY ALL THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242210 REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25 SHOULDER GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0155 2006582 07630040706421

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention