MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R; KNEE TIBIAL COMPONENT CEMENTED

Model Number	02.12.T3I4R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-aug-2021: lot 1905098: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-nov-10.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 implants involved: gmk-sphere 02.12.0024r femoral component sphere cemented size 4+ r (k140826) lot.1905089 lot 1905089: (b)(4) items manufactured and released on 4-oct-2019.Expiration date: 2024-sept-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.12.0413crr tibial insert fixed sphere cr size 4/13 mm r (k181635) lot.185624 lot 185624: (b)(4) items manufactured and released on 16-oct-2018.Expiration date: 2023-sept-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
1 year and 5 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, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: KNEE TIBIAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12432335
• Report Number: 3005180920-2021-00718
• Device Sequence Number: 19660306
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 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): 09/07/2021

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: 11/10/2024
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 1905098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/07/2021
• 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