MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30; SHOULDER REVERSE BASEPLATE

Model Number	04.01.0191
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X30
• Common Device Name: SHOULDER REVERSE BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11162448
• Report Number: 3005180920-2021-00033
• Device Sequence Number: 3717560
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2024
• Device Model Number: 04.01.0191
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 1904749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention