MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/17MM; KNEE TIBIAL INSERT

Model Number 02.07.0517PSF

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 january 2020: lot 185020: (b)(4) items manufactured and released on 26-jul-2018.Expiration date: 2023-07-09.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 due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and poly-swap 3 months after primary.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/17MM
• 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; switzerland
• MDR Report Key: 9693705
• MDR Text Key: 188225503
• Report Number: 3005180920-2020-00057
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030818547
• UDI-Public: 07630030818547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• 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,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: 02.07.0517PSF
• Device Catalogue Number: 02.07.0517PSF
• Device Lot Number: 185020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2018
• 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