MAUDE Adverse Event Report: TORNIER S.A.S. HLS UNI EVOLUTION; FEMORAL UNICOMPARTIMENTAL KNEE PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/02/1998

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.

Event Description

It was reported that a patient underwent revision surgery.No additional details were provided.The implanted femoral component was removed and replaced by a new one.

• Brand Name: HLS UNI EVOLUTION
• Type of Device: FEMORAL UNICOMPARTIMENTAL KNEE PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 56523528
• MDR Report Key: 6040860
• MDR Text Key: 57857667
• Report Number: 3000931034-2016-00171
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other