MAUDE Adverse Event Report: DEPUY IRELAND 9616671 UNK ATTUNE KNEE TIBIAL INSERT

Catalog Number UNK ATTUNE KNEE TIBIAL INSERT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).All devices on this complaint were also the subject of (b)(4) as the patient experienced adverse events on different days with the same devices.(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Voluntary report received ( mw5110735 ).Patient stated, "i had a total right knee arthroplasty surgery on 2021 at hospital outpatient center.I was sent home the same day 2021 after surgery due to covid-19 cases in the hospital and the lack of beds available.I had home health care which included a nurse and physical therapist assigned to me for 3 weeks corning to my home.After my removal of my surgical staples, i received physical therapy at a the physical therapy center in.During my recovery, i constantly was in pain, swelling knee and discomfort and my healing process did not seem to be working.From (after facility physical therapy sessions), i made several follow-up appts with the doctor office about my progress however due to covid and trying to avoid getting any infections during this period, i tried to manage the pain at home.During the doctor visitors, numerous non-operative treatments such as nsaids, x-rays, home exercise programs, etc with my surgical doctor resulted in no relieve of the pain and discomfort.Henceforth in 2022, the doctor decided to try some pain management treatments with another doctor within the organization.After numerous pain management injections, narcotics, and opioids from 2022, i was still in pain and the knee had really bowed outward causing me back pain and walking with a constant leg pain as if it felt like it was detaching from my shin in the leg.I kept a constant pain in the back of my leg.My 12 diagnosis was that my symptoms were interfering not only with recreational activities but also with adl.X-rays demonstrate possible medial tibial component subsidence and periprosthetic lucencies.The conclusion after 13 months of treatment was to perform a total knee arthroplasty revision.While waiting for surgery, i started searching to see if others had similar cases such as mine with a total knee replacement.I discovered that there were knee replacements that had been on recall, etc.I ask the doctor office staff to request a copy of the name of the company and other information about the knee devices that was implanted within me.I received that information.I observed that the company that made my knee was depuy attune.I contacted a lawyer via email to ask about this.As i waited from a response from the online lawyer firm, i contacted the fda to ask about the depuy knee replacements and if there were any recalls or problems reported.I stated that i had a problem with my knee implant as it had bowed outward, and i was going to have to have a revision knee replacement performed in a few weeks.A law firm did contact me and stated they were handling lawsuits involving the depuy attune knee devices.The lawyer requested to the hospital that they wanted the old knee device to have it analysis for any default.The law firm sent a letter to regional hospital requesting the knee be saved and they will retrieve it and pay for the cost to clean it up.I had the right total knee arthroplasty revision surgery on 2022.I am currently in recovery at home.My understanding is that i received a new knee replacement.The depuy attune knee came loose.I have not seen the doctor notes yet that was written after surgery, nor do i know the brand knee i now have as a new replacement.The patient summary shows the new device identifier lot or batch number and expiration date but not the manufacturer of the new device.I am filing this complaint as i have a concern that i was sold a faulty knee that cost me pain for 8 additional months then i should have endured, and i had to pay for surgery twice to have this new replacement.I could not return to work after the pandemic from teleworking due to my knee pain and the lack of driving with my right leg i was able to do to get to work.Therefore, this depuy knee caused me 2 years of additional work salary prior to my retirement.Due to the strain on my lower back from walking with a limp in the total right knee replacement, i also visited a local chiropractor for chiropractic therapy.The device was requested by this law firm to have it tested for any defects.".

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: ATTUNE KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15173972
• MDR Text Key: 297319457
• Report Number: 1818910-2022-15169
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ATTUNE MEDIAL DOME PAT 32MM.; UNK ATTUNE FEMORAL.; UNK ATTUNE KNEE TIBIAL INSERT.; UNK ATTUNE KNEE TIBIAL TRAY.; UNKNOWN BONE CEMENT.
• Patient Outcome(s): Required Intervention