MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE FEMORAL

Catalog Number UNK ATTUNE FEMORAL

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

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient underwent a right total knee arthroplasty on (b)(6) 2015 secondary to pain and arthritis.Attune implants were used.Unknown cement was used.The patella was resurfaced.No intraoperative complications noted.The patient underwent right knee manipulation on (b)(6) 2016 under anesthesia secondary to arthrofibrosis.The patient underwent a revision on the right knee on (b)(6) 2018 secondary to pain and suspected loosening.Intraoperatively, the surgeon confirmed loosening of the tibial component at the cement to implant interface.The femoral and patellar components were well-fixed.There were no intraoperative complications noted.Pmh: synovitis and large knee; joint effusion; degenerative joint disease (right knee) and morbid obesity doi: (b)(6) 2015, doe: (b)(6) 2016 dor: (b)(6) 20,18 (rt knee).

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.Product complaint # : (b)(4).Investigation summary: the device associated with this report was not 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.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: UNK ATTUNE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9577546
• MDR Text Key: 186736735
• Report Number: 1818910-2020-01502
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR