MAUDE Adverse Event Report: SMITH-NEPHEW / INTEGRA LIFESCIENCES CORPORATION INTEGRA IMPLANT; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 04/18/2022

Event Type  Injury  

Event Description

I had an implant done in (b)(6) 2019 to remove a previous implant (cartiva) into my second toe in 2019 by another surgeon, and this implant caused me terrible pain.So, i reached out to another surgeon and she found the first implant by another manufacturer was backing out and this is what was causing my pain.The implant was removed and the integra implant was done on (b)(6) 2020, which only lasted a year of having it implanted.I began to endure pain and tried to contact the surgeon; but she had left the practice.I seen a colleague of hers on (b)(6) 2021; but she was not familiar with implants.In any case, i went to a new surgeon (dr.(b)(6) in (b)(6) and he found that the implant had broken in 2 pieces in my second toe and had to use a fluoroscope to retrieve many other pieces 8 pieces floating around.This doctor removed the integra implant on (b)(6) 2022.It was the opinion of the doctor, this should not had been implanted in my second toe due to lack of bone.I contact smith-nephew and sent them my surgical records and they came back it was found there was some health issues, which i came back with i am a healthy individual; however, i do have osteoporosis which was disclosed to the previous surgeon and she said there would be no problem.Smith-nephew asked me for the model, which i could not provide since i was in surgery when the pieces were removed and they said, they would need it to review the device.I was surprised because in the surgical notes from my first surgery it was not identified either, which is my understanding all medical devices must have an identifier when a surgeon implanting any device.I found it peculiar, when smith-nephew responded to my complaint they also stated that the device model has never had any complaints, well if i didn't provide the device identifier as i told them how would they know that the device had no issues.I write to you since, it appears they are not going to do anything, i did, however, was contacted by a gentlemen from chubb's which is the insurance company and he asked me several questions, one being do i have an attorney and i replied not at this time.This gentlemen stated he would send me an email listing what he would expect from me.As of this date, i have received nothing, however, i did put together a spreadsheet with documentation and the compensation i feel i should receive.I feel your organization, if i have the right location would want to investigate so no other individual would experience what i had.Regards, (b)(6).I could not obtain this information, was never shared with me; however, smith-nephew told me they would monitor this device.Strange they want me to send it to them; plus no identifier on package.Plus, as noted i was under anesthesia.I did send the information to a ms (b)(6) at the fda; but to no avail never heard back from her.I am still under doctor's care to make sure i am not experiencing any more pain; but my toe now is not the same.The doctor who removed the implant dr.(b)(6) in (b)(6) stated that no implant should have been put in my toe, it should have been fused.The toe affected was my second toe.You will read that not only was the implant broken in two places, i had 8 floaters that they had to search for.I had 2 implants previously a cartiva, then the integra; which was told the best; which failed too, then dr.(b)(6) removed it as noted above.Reference report: mw5117321.

• Brand Name: INTEGRA IMPLANT
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): SMITH-NEPHEW / INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 16887322
• MDR Text Key: 314847405
• Report Number: MW5117322
• Device Sequence Number: 1
• Product Code: KWH
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CITRATE; KRILL OIL; VIT D 3
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White