MAUDE Adverse Event Report: TORNIER S.A.S. BIPOLAR RADIAL HEAD; HEMI RADIAL ELBOW PROSTHESIS

Model Number DIAMETER 22 MM

Device Problem Disassembly (1168)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

This is the initial 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 the radial head of the prosthesis was disassembled from the stem at 6 weeks post operatively.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

• Brand Name: BIPOLAR RADIAL HEAD
• Type of Device: HEMI RADIAL ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoiser; montbonnot saint martin, 38330 ; FR 38330 ; 3456523528
• MDR Report Key: 6367482
• MDR Text Key: 68596186
• Report Number: 3000931034-2017-00064
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 03700386901249
• UDI-Public: 03700386901249
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K994041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: DIAMETER 22 MM
• Device Catalogue Number: DTJ022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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