MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE IMPLANT

Catalog Number UNK ATTUNE KNEE TIBIAL INSERT

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)

Event Date 01/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "short term patient outcomes after total knee arthroplasty: does the implant matter?" written by ilda b.Molloy, benjamin j.Keeney, michael b.Sparks, nicholas g.Paddock, karl m.Koenig, wayne e.Moschetti, and david s.Jevsevar published by the knee (2019) 687-699 accepted by publisher 27 january 2019 was reviewed.The article's purpose "was to compare two different tka implants using patient-reported outcomes." data was compiled from 2116 total knee arthroplasties of primary unilateral and bilateral tkas implanted between april 2011 through july 2016.Cement manufacturer was not identified.Patella resurfacing was not reported.Depuy products utilized: sigma knee system, attune knee system adverse events associated with sigma knee system: wound dehiscense treated by re-operation, infection treated by re-operation, patellar maltracking treated by re-operation adverse events associated with attune knee system: wound dehiscense treated by re-operation, infection treated by re-operation, hemarthrosis treated by re-operation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: ATTUNE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9595763
• MDR Text Key: 178337850
• Report Number: 1818910-2020-01954
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention