MAUDE Adverse Event Report: OPTIMOTION IMPLANTS, LLC OPTIMOTION BLUE TOTAL KNEE IMPLANT

Model Number 101-11303-002

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 07/09/2022

Event Type  Injury  

Manufacturer Narrative

On 7/25/2022, optimotion ceo received an anonymous medwatch report mw5110831 from the fda.A patient indicated that they obtained a serious injury from implantation of the optimotion blue total knee implant.Optimotion implants generated a complaint form cf (b)(4) in order to investigate the complaint.As part of the investigation, device history record information, risk documentation, product labeling, and previous complaints were reviewed.Additionally, a medical device reporting assessment took place.During the investigation, it was discovered that a patella from an alternate company (stryker?) was likely used.The patient provided part numbers of their implant components.One of the part numbers did not belong to optimotion implants.Patient indicated that they believed a stryker liner was used, however the investigation proved otherwise as noted previously.A stryker liner is not mechanically compatible with the optimotion implants system.Because the report was made anonymously and the device remains implanted in the patient, we were unable to perform an investigation on the physical implant and medical records specific to the patient.The patient stated that the surgeon who performed the surgery indicated during a follow up visit that the ct scan and bone scan revealed that the implant was secure with no abnormalities.During the review of dhr, dhf, and applicable risk documentation, there were no issues of note and documentation was complete.No previous related complaints were received pertaining to the provided part/lot numbers.As part of the ifu investigation, it should be noted that the "warning" section indicates the following: "except where noted, optimotion implants, llc.Strongly advises against the use of another manufacturer's total knee component with any of optimotion¿ blue total knee system components.Any such use will negate the responsibility of optimotion implants, llc.For the performance of the resulting mixed component implant." ultimately, a final root cause cannot effectively be determined.However, it is possible that off-label use by the surgeon of another manufacturer's component may be contributing to the patient's indicated pain.Although it cannot be determined whether this complaint is directly associated with the optimotion blue total knee system product, a medical device reporting flowchart was completed and it was determined that optimotion implants should report the serious injury out of an abundance of caution.No corrective actions took place due to the limited information and lack of related complaints.

Event Description

Problem as described by patient in medwatch report received by optimotion implants on (b)(6) 2022 - "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.(b)(6) 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).".

• Brand Name: OPTIMOTION BLUE TOTAL KNEE IMPLANT
• Type of Device: TOTAL KNEE
• Manufacturer (Section D): OPTIMOTION IMPLANTS, LLC; 6052 turkey lake rd; suite 170; orlando FL 32819
• Manufacturer (Section G): OPTIMOTION IMPLANTS, LLC; 6052 turkey lake rd; suite 170; orlando FL 32819
• Manufacturer Contact: andrew rynearson ; 6052 turkey lake rd; suite 170; orlando, FL 32819 ; 8776786686
• MDR Report Key: 15568500
• MDR Text Key: 301480056
• Report Number: 3016470314-2022-00001
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2022

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?: No
• Device Model Number: 101-11303-002
• Device Catalogue Number: 1014-F-0302
• Device Lot Number: 1016B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 10/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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): Other