MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.EIF5.08.RM E-CROSS TIBIAL INSERT FIX S5 RM - 8MM; KNEE TIBIAL INSERT

Model Number 02.18.EIF5.08.RM

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/12/2022

Event Type  Injury  

Event Description

The patient came in due to signs of infection and the pathogen is unknown.About 3 months after the primary surgery, the surgeon performed a washout and revised the tibial insert.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 19 december 2022.Lot 2110446: (b)(4) items manufactured and released on 01-dec-2021.Expiration date: 2026-nov-17.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.

• Brand Name: MOTO PARTIAL KNEE 02.18.EIF5.08.RM E-CROSS TIBIAL INSERT FIX S5 RM - 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16067291
• MDR Text Key: 306325490
• Report Number: 3005180920-2022-00982
• Device Sequence Number: 1
• Product Code: HSX
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.EIF5.08.RM
• Device Catalogue Number: 02.18.EIF5.08.RM
• Device Lot Number: 2110446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2021
• 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 Age: 63 YR
• Patient Sex: Male