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

Model Number CUP Ø 22 MM

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190); Missing Value Reason (3192)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 04/11/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Subluxation found in x-ray films.Revision surgery for changing all components done on (b)(6) 2015.

Manufacturer Narrative

Medical device is manufactured in accordance with our specifications.Surgeon thinks he set the implant in overly in proximal position at 1st surgery 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.Not returned to manufacturer.

Event Description

Subluxation found in x-ray films.Revision surgery for changing all components done on (b)(6) 2015.

• Brand Name: BIPOLAR RADIAL HEAD PROSTHESIS
• Type of Device: BIPOLAR RADIAL HEAD PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: segolene pollet ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 76613500
• MDR Report Key: 5288945
• MDR Text Key: 176489507
• Report Number: 3000931034-2015-00102
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K994041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: CUP Ø 22 MM
• Device Catalogue Number: DTJ022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2014
• 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
• Patient Age: 30 YR
• Patient Weight: 115