MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/20 MM L; KNEE TIBIAL INSERT

Model Number 02.12.0620FL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2023: lot 2005793: (b)(4)items manufactured and released on 06-aug-2020.Expiration date: 2025-07-22.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.Clinical evaluation performed by medacta medical affairs director: this tka patient had a former tkr which got infected.Few months after two-stage revision (which was the object of a former report), the scar tissue prevents full extension.The surgeon opens the joint and proceeds to removing the obstructing tissue; during this operation, as customary, the pe insert is exchanged to a new one, although there was no malfunction.

Event Description

The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.On (b)(6)2022, the patient came in and had the spacer removed and was implanted with permanent hardware.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to the inability to come to full extension due to the development of excess scar tissue.The surgeon performed an i&d (incision& drainage) and swapped the poly (20 mm to 17 mm).The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/20 MM L
• Type of Device: KNEE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16859104
• MDR Text Key: 314438618
• Report Number: 3005180920-2023-00324
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030827099
• UDI-Public: 07630030827099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121416
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.0620FL
• Device Catalogue Number: 02.12.0620FL
• Device Lot Number: 2005793
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2020
• 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
• Patient Sex: Male