MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM; KNEE TIBIAL INSET

Model Number 02.07.0510SF

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 january 2020: lot 1811637: (b)(4) items manufactured and released on 15.05.2019.Expiration date: 2024-05-01.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 since 2016.

Event Description

Revision surgery performed 3 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 5 / 10 MM
• Type of Device: KNEE TIBIAL INSET
• 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: 9693700
• MDR Text Key: 188224891
• Report Number: 3005180920-2020-00043
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030818240
• UDI-Public: 07630030818240
• 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
• Report Date: 02/11/2020

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: 05/01/2024
• Device Model Number: 02.07.0510SF
• Device Catalogue Number: 02.07.0510SF
• Device Lot Number: 1811637
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2020
• 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