MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0420SCF FIXED TIBIAL INSERT SC SIZE 4/20MM; KNEE FIXED TIBIAL INSERT

Model Number 02.07.0420SCF

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/02/2022

Event Type  Injury  

Event Description

At about 4 months and 2 weeks after the first revision surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.Competitor components were implanted during the primary surgery and in the first revision surgery the patient was revised to medacta revision components.

Manufacturer Narrative

Batch review performed on 13-dec-2022.Lot 1906430: (b)(4) items manufactured and released on 03-sep-2019.Expiration date: 2024-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other 3 similar reported case during the period of review.

• Brand Name: GMK-REVISION 02.07.0420SCF FIXED TIBIAL INSERT SC SIZE 4/20MM
• Type of Device: KNEE FIXED TIBIAL INSERT
• 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: 16015099
• MDR Text Key: 305812542
• Report Number: 3005180920-2022-00966
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103170
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.07.0420SCF
• Device Catalogue Number: 02.07.0420SCF
• Device Lot Number: 1906430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2019
• 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: Male