BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30

    MDR report key: 11162448 · Received January 13, 2021

    Report

    Report Number
    3005180920-2021-00033
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 13, 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 · 1

    BATCH REVIEW PERFORMED ON 12 JANUARY 2021: LOT 1904749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2019. EXPIRATION DATE: 2024-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 12 JANUARY 2021: REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) LOT 1811895: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2019. EXPIRATION DATE: 2024-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT 1910943: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452)LOT 1910943: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT 2001153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2020. EXPIRATION DATE: 2025-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT 1909137: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 2025-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0215 LONG HUMERAL DIAPHYSIS - L160 - 8 (K170452) LOT 1900926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JULY-2019. EXPIRATION DATE: 2024-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT 1910875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN HAS BEEN IDENTIFIED AS ENTEROCOCCUS FAECALIS. THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS, AND PLACED A TEMPORARY ANTIBIOTIC SPACER, 4 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56198 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30 SHOULDER REVERSE BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0191 1904749 07630040715478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention