MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE E-CROSS TIBIAL INSERT FIX S6 LM - 8MM; KNEE TIBIAL INSERT

Catalog Number 02.18.EIF6.08.LM

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 july 2023.Lot 2116949: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2027-jan-03.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.

Event Description

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

• Brand Name: MOTO PARTIAL KNEE E-CROSS TIBIAL INSERT FIX S6 LM - 8MM
• Type of Device: 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: 17387500
• MDR Text Key: 319664984
• Report Number: 3005180920-2023-00588
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630345712103
• UDI-Public: 07630345712103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.EIF6.08.LM
• Device Lot Number: 2116949
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2022
• 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: Male