MAUDE Adverse Event Report: TORNIER S.A.S. HLS NOETOS SYSTEM; TOTAL ANATOMICAL KNEE PROSTHESIS FIXED TIBIAL TRAY

Model Number	SIZE 3 CEMENTED
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
Tibial component off cement causes pain.Tibial component loosening.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: HLS NOETOS SYSTEM
• Common Device Name: TOTAL ANATOMICAL KNEE PROSTHESIS FIXED TIBIAL TRAY
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5856023
• Report Number: 3000931034-2016-00109
• Device Sequence Number: 16251008
• Product Code: JWH
• UDI-Device Identifier: 03700386910906
• UDI-Public: 03700386910906
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K013906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 02/28/2019
• Device Model Number: SIZE 3 CEMENTED
• Device Catalogue Number: GDF033
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other