MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM; KNEE FIXED TIBIAL INSERT

Model Number 02.07.0312SCF

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Loss of Range of Motion (2032)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 01 april 2022.Lot 187612: (b)(4) items manufactured and released on 13-nov-2018.Expiration date: 2023-10-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

The patient was implanted with competitor knee components.On (b)(6) 2021, the patient had the competitor components removed due to an infection and the surgeon implanted an insert and femoral component as a spacer.The surgery was completed successfully.On (b)(6) 2022 the patient had the spacer removed and the surgeon revised the patient with all new medacta hardware.The surgery was completed successfully.Presently, on (b)(6) 2022 the patient came in reporting tightness in the knee and the cause of the tightness is unknown.The surgeon revised the liner (20 mm to 10 mm) and the surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
• Type of Device: KNEE 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: 13975654
• MDR Text Key: 288361368
• Report Number: 3005180920-2022-00217
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817175
• UDI-Public: 07630030817175
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2023
• Device Model Number: 02.07.0312SCF
• Device Catalogue Number: 02.07.0312SCF
• Device Lot Number: 187612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2018
• 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