MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640608

Device Problem Difficult to Remove (1528)

Patient Problem Not Applicable (3189)

Event Date 02/27/2019

Event Type  malfunction  

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.

Event Description

It was reported that the insert would not snap into the tibial tray during the primary total 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: 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 FB INSRT SZ 6 8MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8433244
• MDR Text Key: 139221843
• Report Number: 1818910-2019-87777
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050094
• UDI-Public: 10603295050094
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151640608
• Device Lot Number: J20K32
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR