MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L; KNEE TIBIAL TRAY CEMENTED

Model Number	02.07.1206L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 2 months from primary surgery the surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 march 2022: lot 1910498: 34 items manufactured and released on 06-apr-2020.Expiration date: 2025-03-29.No anomalies found related to the problem.To date, 20 items of the same lot have been sold without any similar reported event.Additional components involved: batch review performed on 28 march 2022: gmk-sphere 02.12.0026l femoral component sphere cemented size 6+ l (k140826) lot 2000512: 49 items manufactured and released on 29-apr-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, 34 items of the same lot have been sold without any similar reported event.Gmk-sphere 02.12.0613fl tibial insert fixed sphere flex size 6/13 mm l (k140826) lot 176163: 25 items manufactured and released on 30-jan-2018.Expiration date: 2023-01-15.No anomalies found related to the problem.To date, 6 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 2 months from primary surgery the surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.On the (b)(6) 2022 the spacer was removed and permanent implant inserted in the patient.
Additional Manufacturer Narrative
On the 7 june 2022 medacta usa informed medacta international that on the (b)(6) 2022 the spacer was removed and permanent implant inserted in the patient.

• Brand Name: GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• 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: 14160016
• Report Number: 3005180920-2022-00266
• Device Sequence Number: 2846014
• Product Code: JWH
• UDI-Device Identifier: 07630030819940
• UDI-Public: 07630030819940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 03/29/2025
• Device Model Number: 02.07.1206L
• Device Catalogue Number: 02.07.1206L
• Device Lot Number: 1910498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2020
• 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: Male