MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L E-CROSS; KNEE FIXED TIBIAL INSERT

Model Number	02.12.E0414FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 7 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 january 2022: lot 2002484: (b)(4) items manufactured and released on 14-july-2020.Expiration date: 2025-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988), lot.2009482.Batch review performed on 27 january 2022: lot 2009482: (b)(4) items manufactured and released on 23-dec-2020.Expiration date: 2025-12-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-sphere 02.12.0006l femoral component sphere cemented size 6 l (k121416), lot.2100338.Batch review performed on 27 january 2022.Lot 2100338: (b)(4) items manufactured and released on 01-apr-2021.Expiration date: 2026-03-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L E-CROSS
• Common Device Name: KNEE FIXED TIBIAL INSERT
• 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: 13504883
• Report Number: 3005180920-2022-00118
• Device Sequence Number: 3743709
• Product Code: JWH
• UDI-Device Identifier: 07630971261914
• UDI-Public: 07630971261914
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 07/03/2025
• Device Model Number: 02.12.E0414FL
• Device Catalogue Number: 02.12.E0414FL
• Device Lot Number: 2002484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2020
• 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: Unknown