MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM; KNEE FIXED TIBIAL INSERT

Catalog Number	02.07.0310SCF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year after medacta primary surgery, 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.Patient had competitor components prior to medacta revision system implantation.
Additional Manufacturer Narrative
Batch review performed on 18-mar-2024.Lot 2238093: (b)(4) items manufactured and released on 29-nov-2022.Expiration date: 2027-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-revision 02.07.0683l revision fixed tibial tray cemented size 3 l (k123721) lot 2215011: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.2403l femur revision ps size 3 l (k102437) lot 2207826: (b)(4) items manufactured and released on 25-aug-2022.Expiration date: 2027-07-28.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM
• 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: 19077327
• Report Number: 3005180920-2024-00192
• Device Sequence Number: 15058965
• Product Code: JWH
• UDI-Device Identifier: 07630030817076
• UDI-Public: 07630030817076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• 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): 04/10/2024

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 Catalogue Number: 02.07.0310SCF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• 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 Sex: Female
• Patient Race: White