MAUDE Adverse Event Report: CONFORMIS INC. COMFORMIS CUSTOM KNEE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED CEMENTED METAL / POLYMER

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 05/15/2018

Event Type  Injury  

Event Description

Following left knee replacement surgery, i was using the prescribed pedal equipment for rehab and my left knee caught / pinched tissue in the back.Severe pain and unable to straighten leg or bare weight on it.After 10 mins and many tries, i was able to force my leg straight and the pain went away.This continued over the next year several times a day to several times a week.Result was having a left knee revision on (b)(6) 2019 where it was discovered that the poly spacer locking mechanism was broken.A new spacer was placed.This is a comforts custom total knee replacement.For a year i suffered with pain and fear of my knee "catching" with no answer from the surgeon as to why.I had to pay for the surgery and 3 replacement parts, even the two that weren't used of which one didn't even fit properly.I am frustrated and still concerned it will start happening again.Multiple xrays were taken and i eventually had a second opinion with a new dr and new xray.The second opinion dr suspected the poly spacer as it didn't look good on the xray.Fda safety report id# (b)(4).

• Brand Name: COMFORMIS CUSTOM KNEE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED CEMENTED METAL / POLYMER
• Manufacturer (Section D): CONFORMIS INC.
• MDR Report Key: 8730873
• MDR Text Key: 149269644
• Report Number: MW5087576
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR