MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 3 R; KNEE FEMORAL COMPONENT

Model Number	02.09.2603R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022, lot 189374: lot 189374: 20 items manufactured and released on 25-apr-2019.Expiration date: 2024-feb-19.No anomalies found related to the problem.To date, all items of the same lot have been sold with 1 similar reported event during the period of review.Additional implanted components: batch review performed on 11 july 2022 gmk-hinge 02.09.0220uch uc fixed tibial insert size 2/20mm (k172347) lot.183630: lot 183630: 11 items manufactured and released on 21-aug-2018.Expiration date: 2023-jul.24.No anomalies found related to the problem.To date, 6 items of the same lot have been sold with 3 similar reported events during the period of review.Batch review performed on 11 july 2022 gmk-hinge 02.09.4002r fixed tibial tray size 2 r (k130299) lot.189378: lot 189378: 24 items manufactured and released on 14-dec-2018.Expiration date: 2023-dec-04.No anomalies found related to the problem.To date, 23 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 3 years and 2 months after the primary surgery, the surgeon performed a washout, removed all components, and fused the patient's knee.The surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 3 R
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 15093711
• Report Number: 3005180920-2022-00571
• Device Sequence Number: 4034488
• Product Code: KRO
• UDI-Device Identifier: 07630030825446
• UDI-Public: 07630030825446
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 07/25/2022

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: 02/19/2024
• Device Model Number: 02.09.2603R
• Device Catalogue Number: 02.09.2603R
• Device Lot Number: 189374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2019
• 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: Female