MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 12 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0412FUC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 january 2024: lot 1902813: (b)(4) manufactured and released on 03-july-2019.Expiration date: 2024-06-16.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with another similar reported event during the period of review.Additional devices involved batch reviews performed on 22 january 2024 gmk-primary 02.07.1204l tibial tray fixed cemented size 4 (k090988) lot 2246691: (b)(4) manufactured and released on 15-march-2023.Expiration date: 2028-02-26.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Gmk-primary 02.07.2004l femur std cemented size 4 l (k090988) lot 2215947: (b)(4) manufactured and released on 29-sep-2022.Expiration date: 2027-09-18.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 8 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18648850
• Report Number: 3005180920-2024-00028
• Device Sequence Number: 12540555
• Product Code: JWH
• UDI-Device Identifier: 07630030817717
• UDI-Public: 07630030817717
• 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: 2023
• Device Explanted Year: 2024
• 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): 02/06/2024

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: 06/16/2024
• Device Catalogue Number: 02.07.0412FUC
• Device Lot Number: 1902813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2019
• 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: Male