MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/20 MM R; KNEE CEMENTED TIBIAL TRAY

Model Number	02.12.0220FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(4) 2020: lot 173801: (b)(4) items manufactured and released on 30-nov-2017.Expiration date: 2022-11-13.No anomalies found related to the problem.To date, 1 item of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2020, the surgeon decided to resurface the patient's patella.The reason for this additional procedure is unknown.The agent was not notified of this procedure until present and a complaint was not filed.Presently, on (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/20 MM R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10499302
• Report Number: 3005180920-2020-00587
• Device Sequence Number: 2680101
• Product Code: JWH
• UDI-Device Identifier: 07630030826306
• UDI-Public: 07630030826306
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 09/07/2020

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: 11/13/2022
• Device Model Number: 02.12.0220FR
• Device Catalogue Number: 02.12.0220FR
• Device Lot Number: 173801
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/07/2020
• 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