MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

Model Number	02.07.0410FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 april 2022: lot 136085: (b)(4).Expiration date: 2019-02-28.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At about 7 years and 2 months from the primary the surgeon performed a washout and revised the poly and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
• Common Device Name: TIBIAL INSERT UC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14247702
• Report Number: 3005180920-2022-00310
• Device Sequence Number: 4774060
• Product Code: JWH
• UDI-Device Identifier: 07630030817618
• UDI-Public: 07630030817618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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: 02/28/2019
• Device Model Number: 02.07.0410FUC
• Device Catalogue Number: 02.07.0410FUC
• Device Lot Number: 136085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2014
• 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: Unknown