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

Catalog Number 02.18.IF4.08.RM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 17 september 2018.Lot 167805: (b)(4) items manufactured and released on 9 january 2017.Expiration date: 13.12.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

Revision performed due to infection after three months from primary surgery.The surgeon revised the insert.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 RM - 8MM
• Type of Device: TIBIAL INSERT FIX
• 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: 7888903
• MDR Text Key: 120711405
• Report Number: 3005180920-2018-00695
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2021
• Device Catalogue Number: 02.18.IF4.08.RM
• Device Lot Number: 167805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2017
• 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