MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 RM - 8MM

Model Number 02.18.IF6.08.RM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 january 2020: lot 167829: (b)(4) items manufactured and released on 14-dec-2016.Expiration date: 2021-11-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in reporting pain due to a hematoma in the knee.The cause of the hematoma is unknown.The surgeon performed an washout and poly-swap almost 3 weeks after primary.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S6 RM - 8MM
• Type of Device: KNEE TIBIAL INSERT
• 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: 9664310
• MDR Text Key: 177803184
• Report Number: 3005180920-2020-00022
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896347
• UDI-Public: 07630030896347
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Model Number: 02.18.IF6.08.RM
• Device Catalogue Number: 02.18.IF6.08.RM
• Device Lot Number: 167829
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2016
• 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