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

Model Number 02.18.IF3.09.LM

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 march 2023: lot 2207120: (b)(4) manufactured and released on 15-jun-2022.Expiration date: 2027-may-19.No anomalies found related to the problem.To date, (b)(4) 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 infection and the pathogen was unknown.About 2 months after the primary surgery, the surgeon performed a washout and poly swap and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 9MM
• 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: 16723120
• MDR Text Key: 313108953
• Report Number: 3005180920-2023-00242
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895999
• UDI-Public: 07630030895999
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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.LM
• Device Catalogue Number: 02.18.IF3.09.LM
• Device Lot Number: 2207120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2022
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 88 KG