MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0208
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12688216
• Report Number: 3005180920-2021-00821
• Device Sequence Number: 14456089
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 03/21/2025
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 2004003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2021
• Initial Report FDA Received Date: 10/25/2021
• 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