MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151810035

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

Patient Problems Adhesion(s) (1695); Pain (1994); Scarring (2061); Osteolysis (2377); Fibrosis (3167); No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

(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

Medical records received ad 17 june 2019.The patient underwent a left knee revision due to pain, fibrosis, synovial adhesions, scarring, and osteolysis.The surgeon noted the tibial tray was loose at the cement to implant interface.The surgeon also reported the femoral component had synovial fluid under the components consistent with loosening, however, there was no gross motion.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2014; dor: (b)(6) 2017; left 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE MEDIAL ANAT PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9158116
• MDR Text Key: 161776212
• Report Number: 1818910-2019-107894
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056638
• UDI-Public: 10603295056638
• Combination Product (y/n): N
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 151810035
• Device Lot Number: 3545822
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR