MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 7 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-707

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

Patient Problems Adhesion(s) (1695); Pain (1994); Burning Sensation (2146); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 (mw5113592) received 12/7/2022 stating that the reported components were revised in (b)(6) 2018.The patient had left knee arthroplasty, from the date forward had issues with knee swelling, redness pain and severe burning sensation.I was readmitted to the hospital.On 2017 orthopedic surgeon again as was thought to be an infection in my knee.All cultures were negative for infection.I was in hospital overnight to receive iv abt.I was also sent home on oral abt.Thought was possible allergic reaction to my left knee in swelling.But the pain and burning sensation continues, and my left knee iw warmer to touch than my right.It is my belief now that i may be reacting to the depuy orthopedics bone cement.I was informed the cement used was either cw1 or cw2.I have sent an email to depuy to inquire of any reported events since i saw on your site, their body cement was recalled in 2011.I also left word with my surgeon and his pa about the continued burning sensation and warmth of the knee.Also reported to my physical therapist.The pa of my physician relayed she will discuss matter with the depuy rep as he was available today.I am almost certain it is an allergic reaction to the body cement since i do have numbers of allergies, the knee replacement is of cobalt which is same as my left shoulder replacement, and i did not have a reaction as this post-op shoulder.I am awaiting a call back from my physician or his pa.Additional info received from reporter for report #mw5077099 on 11/21/2017.Had left knee replaced on this date from initial implant.I had major medical issues that persist to this day.Ie: sever pain, swelling with leg dozing fluid burning sensation.On 2017 had superficial debridement done and all cultures negative for infection.On 2017 had neuroma surgery, problems persist.Nuclear test as bone scan, indium and bone marrow scan show no infection of prosthesis.Again this is and still have daily pain/burning sensation of leg and severe swelling occurring.Leg unable to articulate appropriately.I have become an invalid.I still use raised toilet seat and no pain or nerve medication relieve symptoms.I now need to see another surgeon to assess if revision can be done.That appt is 2017.Device still present in my knee.It's depuy attune implant and i will try to attach copy of product id number here to report.Doi: (b)(6) 2017; dor: (b)(6) 2017; dor (2nd): (b)(6) 2018 left knee.

• Brand Name: ATTUNE PS RP INSRT SZ 7 7MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15985832
• MDR Text Key: 305492154
• Report Number: 1818910-2022-25472
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052722
• UDI-Public: 10603295052722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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: 12/15/2022

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 Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1516-50-707
• Device Catalogue Number: 151650707
• Device Lot Number: 8176429
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female