MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM LOT. 2114689; KNEE TIBIAL INSERT

Model Number	02.07.0320SCF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-feb-2023: lot 2114689: 30 items manufactured and released on 22-dec-2021.Expiration date: 2026-12-05.No anomalies found related to the problem.To date, 3 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient had a competitor knee primary surgery and was revised to a medacta knee system on (b)(6) 2022.On (b)(6) 2022, the patient came in due to signs of infection and the pathogen was unknown.The surgeon successfully performed a washout and revised the insert.Presently, on (b)(6) 2023, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised successfully the insert.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM LOT. 2114689
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16494451
• Report Number: 3005180920-2023-00134
• Device Sequence Number: 6611280
• Product Code: JWH
• UDI-Device Identifier: 07630030817519
• UDI-Public: 07630030817519
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 03/07/2023

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 Model Number: 02.07.0320SCF
• Device Catalogue Number: 02.07.0320SCF
• Device Lot Number: 2114689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2021
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White