MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY 02.07.0312SF TIBIAL INSERT STD FIXED SIZE 3/12 MM; KNEE TIBIAL INSERT

Model Number	02.07.0312SF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years 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 implants and implanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24-aug-2022: lot 174619: (b)(4) items manufactured and released on 29-dec-2017.Expiration date: 2022-12-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Other devices involved: batch review performed on 24-aug-2022: gmk-primary 02.07.2003l femur std cemented size 3 l (k090988) lot 184919: (b)(4) items manufactured and released on 04-oct-2018.Expiration date: 2023-09-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported case during the period of review.Gmk-primary 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot 177764: (b)(4) items manufactured and released on 28-feb-2018.Expiration date: 2023-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported case during the period of review.

• Brand Name: GMK-PRIMARY 02.07.0312SF TIBIAL INSERT STD FIXED SIZE 3/12 MM
• 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: 15439031
• Report Number: 3005180920-2022-00701
• Device Sequence Number: 5672803
• Product Code: JWH
• UDI-Device Identifier: 07630030817182
• UDI-Public: 07630030817182
• 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: 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): 09/16/2022

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: 12/05/2022
• Device Model Number: 02.07.0312SF
• Device Catalogue Number: 02.07.0312SF
• Device Lot Number: 174619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2017
• 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