MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 7 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151620705

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Subject: (b)(6).Associated study; dots.Clinical notification received for revision related to instability.Doi: (b)(6) 2017.Dor: (b)(6) 2018.(right 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).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 CR FB INSRT SZ 7 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8419738
• MDR Text Key: 138760902
• Report Number: 1818910-2019-87209
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295045885
• UDI-Public: 10603295045885
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151620705
• Device Lot Number: H45983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 101