MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FEM LT SZ 6 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-126

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/12/2018

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 left knee revision due to tibial tray loosening at the cement to implant interface.The surgeon noted significant distal and posterior medial femoral bone loss.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2015; dor: (b)(6) 2018, left knee.

Manufacturer Narrative

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.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.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.

Manufacturer Narrative

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. 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 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: ATTUNE PS FEM LT SZ 6 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8866403
• MDR Text Key: 153441961
• Report Number: 1818910-2019-100242
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041719
• UDI-Public: 10603295041719
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-126
• Device Catalogue Number: 150410126
• Device Lot Number: 584608
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FB INSRT SZ 6 8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR