MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA EVOLIS 3040.0209 STANDARD INSERT 9MM SIZE 2; KNEE STANDARD INSERT

Catalog Number 3040.0209

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inflammation (1932)

Event Date 12/20/2023

Event Type  Injury  

Event Description

Revision surgery performed 7 years and 11 months after the primary surgery due to irritable knee.Surgeon discovered synovitis in joint and revised the liner.

Manufacturer Narrative

Batch review performed on 22-december-2023 lot 135757: (b)(4) items manufactured and released on 03-feb-2014.Expiration date: 2018-12-31.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.Preliminary investigation performed by r&d manager: based on the analysis of the available pictures, no definitive conclusion can be established.Devices evaluation is required for a comprehensive analysis.

Manufacturer Narrative

Visual inspection performed by r&d project manager: after 7 years and 11 months after tka the patient felt there was an issue.The surgeon discovered synovitis and replaced the liner.The bearing surface of the tibial insert reveals some polished and matte areas with scratch marks oriented in the flexion/extension direction on both medial and lateral condyles.These are common findings in standardized tests with wear simulators, in which the inserts are subjected to cyclic loads for 5 million cycles.It's not possible to quantitatively assess the wear amount, nevertheless, the measurement of polyethylene thickness on the deepest point of both condyles demonstrates a minimum value of around 6.2mm and 6.3mm.As the design dimension for this insert is 6.5mm±0.20mm, the measured thickness suggests that very low wear may have taken place over the years in vivo.No local reactions related to polyethylene wear, such as osteolysis, were reported for this case.In the worn area, mainly on the posterior side of the insert bearing, some regions with plastic deformation (shaped like dots) can be noted, the presence of these "dots" is a common finding in wear tests with third body conditions, suggesting that some hard particles were interposed between the insert and the femoral component.No information/pictures of the articular surface of the femur have been provided and no particles/inclusions have been detected on the bearing surface of the insert.Although third body particles are not detected on the explanted liner, we suspect that they were removed during the cleaning process after explantation.Based on the available information there is no evidence to suspect that the complaint is related to a faulty device.

• Brand Name: EVOLIS 3040.0209 STANDARD INSERT 9MM SIZE 2
• Type of Device: KNEE STANDARD 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: 18541560
• MDR Text Key: 333195332
• Report Number: 3005180920-2023-01093
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030845352
• UDI-Public: 07630030845352
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 3040.0209
• Device Lot Number: 135757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White