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 Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)

Event Date 03/20/2017

Event Type  Injury  

Event Description

Voluntary report received (mw5113219) patient stated: "i had arthritis and saw an orthopedic surgeon.He implanted an attune l knee prothesis.From day 1 i had problems.Severe pain; swelling and even the physical therapist relayed symptoms unusual.I finally had ct done and it showed debonding of prothesis and the original surgeon relayed he does not do revisions i finally found an excellent ortho doctor w/ (b)(6), and he saw results of ct and he replaced the attune device w/ a stryker device.But in interim of follow up from 1st surgery implant of attune device, i had additional surgery for left knee neuroma; then still had issues and swelling.Recently i had the peroneal nerve left knee decompressed by same surgeon who did the revision: dr.(b)(6).The original surgeon and his colleague he sent me to treat me as a hysterical female.Ps i am an rn in my 60's so i know my body very well, and i knew the severe pain i was feeling was not normal.Even dr.(b)(6), the original surgeon, his own therapist had admitted to met the pain and symptoms i was having were very abnormal".

Manufacturer Narrative

Product complaint #: (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.The device catalog number is unknown; therefore, udi # is unavailable.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.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15941486
• MDR Text Key: 305085752
• Report Number: 1818910-2022-24753
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• 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 38MM; ATTUNE RP TIB BASE SZ 6 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; UNKNOWN KNEE FEMORAL
• Patient Outcome(s): Required Intervention