MAUDE Adverse Event Report: CONFORMIS INC. ITOTAL TKR G2; ITOTAL G2

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Swelling (2091)

Event Date 09/18/2014

Event Type  Injury  

Event Description

I had a tkr (total knee replacement) with a conformis i total g2 in (b)(6) of 2014.It never felt right.After one year i went to see my surgeon who told me that the tibial tray had loosened and crushed part of the bone (tibial head).Dr said that the whole thing needed to be replaced, revision surgery.I went to a second surgeon that told me the same thing so i had revision surgery in (b)(6) 2015.Lots of pain and another year of recovery.To make sure the tibial tray stayed in place, they put a 9 inch spike in my tibia and built up part of the tray to account for bone loss.Conformis says that their implants are custom built from a ct scan and that all surgical tools are also custom built for your knee.This is not true from my experience, the surgeon who said that he thought the thing was misaligned causing too much pressure on one side of the joint causing the metal tray to crush the bone.Now after the second surgery, i am walking better, but the leg is still swollen and causes my foot to swell up in my shoe.The doctor has told me that i should expect this to be the case for the rest of my life.This appears to be an extension of the problem that occurred in 2013 and was claimed to be fixed.

• Brand Name: ITOTAL TKR G2
• Type of Device: ITOTAL G2
• Manufacturer (Section D): CONFORMIS INC.
• MDR Report Key: 6338935
• MDR Text Key: 67842035
• Report Number: MW5067928
• Device Sequence Number: 1
• Product Code: HSX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: CALCIUM ; RX MEDS: NONE.; VITAMIN D
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 112