MAUDE Adverse Event Report: TORNIER SAS CRF II; NONE

Device Problem Malposition of Device (2616)

Patient Problem Bone Fracture(s) (1870)

Event Type  malfunction  

Event Description

Prosthesis implanted on (b)(6) 2006, during x-ray controls on (b)(6) 2011, it was observed that the prosthesis had an inclined position, which was due to a fracture of the stem.The prosthesis had to be changed on (b)(6) 2013.

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.The info contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on info submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

Manufacturer Narrative

Device and lot number not available for analysis.Root cause of reported event could not be determined.This is the final report submitted regarding this surgical event and medical device.

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.Following additional information from a patient.The prosthesis involved in the medical device report # 9610667-2014-00039 by the breakage of the stem is a mopyc prosthesis and not a crf as initial reported.The mopyc prosthesis is not cleared in usa.We consider that the medical device report # 9610667-2014-00039 is cancelled.

• Brand Name: CRF II
• Type of Device: NONE
• Manufacturer (Section D): TORNIER SAS; montbonnot ; FR
• Manufacturer Contact: mireille lemery ; 161 rue lavoisier; monbonnot cedex 38334 ; FR 38334 ; 76613500
• MDR Report Key: 4189090
• MDR Text Key: 20453710
• Report Number: 9610667-2014-00039
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K994041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2014
• 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): Required Intervention