MAUDE Adverse Event Report: TORNIER SAS HLS UNI EVOLUTION - PE TIBIAL TRAY; NONE

Catalog Number GDU122

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 07/19/2013

Event Type  Injury  

Event Description

Implantation of a unicompartmental knee prosthesis on (b)(6), 2011.Persistent pain 1.5 years after the surgery.Periprosthetic radiolucent lines on tibia and osteocondensation with no osteonecrosis.Aseptic loosening.

Manufacturer Narrative

Method - device history record was reviewed.Results - device was made to specification.Conclusions - device was not returned for evaluation because still implanted.This is the initial and final report submitted regarding this surgical event and medical device.

• Brand Name: HLS UNI EVOLUTION - PE TIBIAL TRAY
• Type of Device: NONE
• Manufacturer (Section D): TORNIER SAS; montbonnot ; FR
• Manufacturer Contact: mireille lemery ; 161 rue lavoisier; monbonnot cedex 38334 ; FR 38334 ; 7661350C
• MDR Report Key: 3738423
• MDR Text Key: 4307064
• Report Number: 9610667-2014-00002
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GDU122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2013
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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