BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5

    MDR report key: 12688216 · Received October 25, 2021

    Report

    Report Number
    3005180920-2021-00821
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728072
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2021. LOT 2004003: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2025-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. ADDITIONAL ITEMS RELATED TO THE EVENT, BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2021. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 179969. LOT 179969: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452) LOT. 2002440. LOT 2002440: (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 THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 2003851. LOT 2003851: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-APR-2021. EXPIRATION DATE: 2026-03-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT. 2100435. LOT 2100435: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 2102243. LOT 2102243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2021. EXPIRATION DATE: 2026-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 (K170452) LOT. 174749. LOT 174749: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2018. EXPIRATION DATE: 2023-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITH 1 OTHER SIMILAR EVENT REPORTED. REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25 (K171058 ) LOT. 1906799. LOT 1906799: (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 THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED. REVERSE SHOULDER SYSTEM 04.01.0007 STD HUMERAL DIAPHYSIS - CEMENTLESS - 12 (K170452) LOT. 176469. LOT 176469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2017. EXPIRATION DATE: 2022-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS LOT HAVE BEEN SOLD WITHOUT OTHER SIMILAR EVENTS REPORTED.

    Description of Event or Problem · 1

    ABOUT 3 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
    1590978 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5 SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0208 2004003 07630040728072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention