BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

    MDR report key: 12860794 · Received November 23, 2021

    Report

    Report Number
    3005180920-2021-00902
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    October 25, 2021
    Report Date
    November 23, 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 04.NOV.2021. LOT 1906800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2020. EXPIRATION DATE: 2025-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 04.NOV.2021. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT. 2010017. LOT 2010017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2020. EXPIRATION DATE: 2025-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. 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: 2025-11-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0183 SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 10 (K180089) LOT. 2012146. LOT 2012146: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-FEB-2021. EXPIRATION DATE: 2026-01-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003820. LOT 2003820: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JAN-2021. EXPIRATION DATE: 2026-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER Ø36/+3MM (K170452) LOT. 2006591. LOT 2006591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 2003864A. LOT 2003864A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-DEC-2020. EXPIRATION DATE: 2025-12-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763415 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30 REVERSE SHOULDER THREADED GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0191 1906800 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention