MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30; REVERSE SHOULDER THREADED GLENOID BASEPLATE

Model Number	04.01.0191
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
• Common Device Name: REVERSE SHOULDER THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12860794
• Report Number: 3005180920-2021-00902
• Device Sequence Number: 3684561
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 02/02/2025
• Device Model Number: 04.01.0191
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 1906800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female