MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM; UNICOMPARTIMENTAL KNEE INSERT PE

Model Number 02.18.IF4.08.RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 may 2022.Lot 2011117: 35 items manufactured and released on 04-jan-2021.Expiration date: 2025-12-13.No anomalies found related to the problem.To date, 24 items of the same lot have been sold without any similar reported event.

Event Description

The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM
• Type of Device: UNICOMPARTIMENTAL KNEE INSERT PE
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 14675383
• MDR Text Key: 294292660
• Report Number: 3005180920-2022-00458
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896101
• UDI-Public: 07630030896101
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.IF4.08.RM
• Device Catalogue Number: 02.18.IF4.08.RM
• Device Lot Number: 2011117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2021
• 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