MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 CEM; FEMORAL COMPONENT

Catalog Number 150400105

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 was revised to address pain and loosening of the tibia at the cement to implant interface, cement manufacturer is unknown.It was also indicated that x ray showed possible loose tibia component.In surgery, tibia was found to be loose.No cement bond on tibial tray.Femur was internally rotated which caused poor patella tracking and patella was undersized.The surgeon removed all components and implanted new attune revision knee components.Doi: (b)(6) 2014; dor: (b)(6) 2017; left knee.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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 FEM LT SZ 5 CEM
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7120587
• MDR Text Key: 94943002
• Report Number: 1818910-2017-51742
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295041061
• UDI-Public: 10603295041061
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150400105
• Device Lot Number: 3607557
• Date Manufacturer Received: 09/14/2018
• Date Device Manufactured: 07/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR