MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 9MM; UNICOMPARTIMENTAL KNEE INSERT

Model Number 02.18.IF3.09.RM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 02/23/2023

Event Type  Injury  

Event Description

At about 1 month after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 02-mar-2023.Lot 2207885: (b)(4) items manufactured and released on 21-jun-2022.Expiration date: 2027-06-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 9MM
• Type of Device: UNICOMPARTIMENTAL KNEE 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 ; strada regina
• MDR Report Key: 16583927
• MDR Text Key: 311690438
• Report Number: 3005180920-2023-00173
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896002
• UDI-Public: 07630030896002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 02.18.IF3.09.RM
• Device Catalogue Number: 02.18.IF3.09.RM
• Device Lot Number: 2207885
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female