MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM

Model Number 02.07.0314SCF

Device Problems Material Too Rigid or Stiff (1544); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Loss of Range of Motion (2032)

Event Date 07/19/2022

Event Type  Injury  

Event Description

The patient had a primary knee surgery on (b)(6) 2019.On (b)(6) 2022, the patient came in reporting pain due to loose implants and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting stiffness and the cause is unknown.The surgeon revised the insert semiconstrained 14mm s3 with an insert semiconstrained 10mm s3.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 17-august-2022.Lot 180467: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-04-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM
• Type of Device: FIXED 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: 15240571
• MDR Text Key: 298049337
• Report Number: 3005180920-2022-00616
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817298
• UDI-Public: 07630030817298
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: 02.07.0314SCF
• Device Catalogue Number: 02.07.0314SCF
• Device Lot Number: 180467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2018
• 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
• Patient Sex: Female