MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM; KNEE FIXED TIBIAL INSERT

Model Number	02.09.0517H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month post primary surgery the surgeon performed a washout and revised the liner for infection.The pathogen is unknown.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 may 2023.Lot 2116822: (b)(4) items manufactured and released on 08-feb-2022.Expiration date: 2027-01-19.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM
• Common Device Name: KNEE FIXED 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17117953
• Report Number: 3005180920-2023-00428
• Device Sequence Number: 17900568
• Product Code: KRO
• UDI-Device Identifier: 07630030825286
• UDI-Public: 07630030825286
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/13/2023

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: 02.09.0517H
• Device Catalogue Number: 02.09.0517H
• Device Lot Number: 2116822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 104 KG