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

Model Number	04.01.0191
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 october.2021.Lot 1904749: (b)(4) items manufactured and released on 4-dec-2019.Expiration date: 2024-nov-24.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.Additional components involved.Reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k193175) lot.2103688.Lot 2103688: (b)(4) items manufactured and released on 4-dec-2019.Expiration date: 2024-nov-24.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot.2103783.Lot 2103783: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-may-06.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events (2 pieces of this lot reported in this complaint).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-nov-18.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot.2006965.Lot 2006965: (b)(4) items manufactured and released on 26-aug-2020.Expiration date: 2025-aug-19.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0007 std humeral diaphysis - cementless - 12 (k170452) lot.2006061.Lot 2006061: (b)(4) items manufactured and released on 20-oct-2020.Expiration date: 2025-oct-08.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2003795.Lot 2003795: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-nov-26.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.Reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot.189839 lot 189839: (b)(4) items manufactured and released on 25-jan-2019.Expiration date: 2024-jan-13.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting instability and looseness and the cause was unknown.The surgeon revised the liner and metaphysis.The surgery was completed successfully.Complaint (b)(4) was filed.Subsequently, on (b)(6) 2021, the patient came in due to a dislocation of the humerus from the glenosphere.The surgeon revised the baseplate, lateralized glenosphere, humeral diaphysis, reverse metaphysis, and liner.The surgery was completed successfully.Complaint (b)(4) was filed.Presently, on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants 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 GLENOID
• 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: 12779042
• Report Number: 3005180920-2021-00867
• Device Sequence Number: 14540687
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 10/11/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2019
• 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: Male