MAUDE Adverse Event Report: OPTIMOTION IMPLANTS, LLC. THE OPTIMOTION BLUE TOTAL KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 1014-F-0302

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 07/29/2020

Event Type  Injury  

Event Description

I had a total knee replacement on (b)(6) 2020.The doctor convinced me to get his device implanted since he had developed it and he told me it was better than stryker, especially with the vitamin e enriched liner, etc.Shortly before the surgery, a letter was sent to me saying that i needed to sign a form stating that i would get his device implanted or he may have another doctor do the surgery if another device was used.Since he was well know for his skills, i wanted to continue with him as my surgeon.On the day of surgery he spoke with me and asked if i was going to go ahead with optimum device and explained to me why it was so much better and any other device so i agreed to it.After surgery, the pain in my knee only got worse and at each follow up visit i told the doctor about it, he said it would take about a year to improve completely.After a year, he told me everything was implanted securely and there was nothing wrong with it (a ct scan and bone scan confirmed this).His pa physically checked it prior to me talking to the doctor and she said it seemed consistent with a problem with the liner.The doctor never physically checked it and said there was not problem.He wanted to give me a cortisone shot for pain, which i refused.I wanted to know what was wrong.He made me feel like it was all in my head and said maybe i should see a rheumatologist.The pains only got worse so i got a second opinion from another doctor who does knee replacements.He told me i needed to get revisionary surgery or radio frequency ablation.I scheduled another meeting with my original doctor and when i got to the appointment, another doctor from his office saw me instead.This doctor told me that he also thought there was a problem with the liner.I scheduled another appointment with the original doctor who invented the device.This time he said there might be a problem with the liner and he could do surgery but couldn't guarantee any results.Because of his demeanor in my follow up visits, i was hesitant to have him do further surgery on the hope that i would have better results.Over time since the knee replacement surgery, my pain caused me to have foot/ankle and hip problems because i was walking abnormally.The pain became so bad in my foot, knee and hip that my other doctors suggested that i have revision surgery done at mayo clinic.In the process of getting an appointment there, i needed to get information regarding the medical device implanted.I called my knee doctor's office multiple times trying to get model #, serial#, etc.Of the device implanted.They totally ghosted me and would not return phone calls or email messages.I finally contacted the surgery center for this information and got the information needed, except the serial number of device.There were multiple pieces of the device listed, including a stryker piece.Surgery center did not know why serial numbers were not shown and said i needed to call the doctor's office.I sent email messages, left phone messages, and they never responded.The information given to me by the surgery center showed that part of the device implanted (i believe the liner) was a stryker device.I am wondering if the problem with the device implanted in my knee was not what was approved by the fda.My pain and problems increase daily and i am not sure what to do about it.Mayo clinic gave me the option of doing a completely knee revision replacement.At this point i don't know what to do.This pain has been life changing for me.I cannot do the activities i used to do and can barely walk more than 2 blocks without having to stop.I hope others haven't had the same results from this device.Fda safety report id# (b)(4).

Event Description

Additional information received from the reporter for report mw5110831 on 11/18/2022.I don't believe the knee replacement device that was implanted in me in (b)(6) 2020 was the device as approved by the fda.I have been in pain and have been told by 3 doctors that it needs to be replaced.I believe the problem may be related to the fact that there was a stryker component used in this device that didn't work with the optimotion components.I have submitted a form fda3500b to the fda in july 2022 with detailed information regarding the device and my problems with it.Please let me know if you need additional information at this time.I may be reached at (b)(6).

• Brand Name: THE OPTIMOTION BLUE TOTAL KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): OPTIMOTION IMPLANTS, LLC.
• MDR Report Key: 15003542
• MDR Text Key: 295900046
• Report Number: MW5110831
• Device Sequence Number: 1
• Product Code: JWH
• 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,Followup
• Report Date: 07/09/2022

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 Model Number: 1014-F-0302
• Device Catalogue Number: THERE ARE MULTIPLE PIECES
• Device Lot Number: 1016B
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2022
• Patient Sequence Number: 1
• Treatment: ALEVE; AMLODIPINE BESYLATE 5 MG ; ASHWAGANDA; CBD ; OBKS CR TIBAL INSERT LOT#1073, MODEL# 1014-P-0315-02; OBKS CR TIBAL INSERT, LOT#1071, MODEL# 1014-P-0313-02; OBKS TIBAL TRAY COMPONENT LOT#1003B, MODEL#1014-B-0300.; OLMESARTAN 40MG ; OMEPROZALE ; PRAVASTATIN 40MG ; RESTATES ESTRADIOL CREAM .01%; TYLENOL ; VARIOUS OTHER VITAMINS/SUPPLEMENTS; VITAMIN D3, C, B12
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White