MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X25

Model Number	04.01.0190
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23.04.2021: lot 187758: (b)(4) items manufactured and released on 2-feb-201.Expiration date: 2024-02-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional item involved in the event: reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot.1906612.Batch review performed on 23.04.2021: lot 1906612: (b)(4) items manufactured and released on 7-nov-19.Expiration date: 2024-10-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
11 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, placed antibiotics, removed the glenosphere and baseplate and converted the humeral component to a hemi-shoulder.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE 24.5X25
• Common Device Name: THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11848918
• Report Number: 3005180920-2021-00403
• Device Sequence Number: 19639454
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• 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: 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): 05/19/2021

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: 02/07/2024
• Device Model Number: 04.01.0190
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 187758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/19/2021
• 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