MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 RM - 8MM

Catalog Number 02.18.IF7.08.RM

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08 may2018.Lot 168078: 24 items manufactured and released on 10 february 2017.Expiration date: 2022-01-04.No anomalies found related to the problem.To date, 1 items of the same lot have been already sold.

Event Description

The patient came in due to signs of infection 5 months after primary.The patient had a uti.The surgeon washed out the knee and swapped the poly.The surgery was completed successfully.Pathogen unknown.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 RM - 8MM
• Type of Device: TIBIAL INSERT FIX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7494731
• MDR Text Key: 107609581
• Report Number: 3005180920-2018-00310
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896460
• UDI-Public: 07630030896460
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Catalogue Number: 02.18.IF7.08.RM
• Device Lot Number: 168078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2017
• 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