MAUDE Adverse Event Report: TORNIER, INC. HUMERAL STEM MEDIUM STANDARD RIGHT

Catalog Number 0030402

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The hospital (b)(6) reported to tornier that the implant was explanted from the same patient due to aseptic loosening.

Manufacturer Narrative

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

• Brand Name: HUMERAL STEM MEDIUM STANDARD RIGHT
• Type of Device: NI
• Manufacturer (Section D): TORNIER, INC.; bloomington MN
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 4616140
• MDR Text Key: 17220021
• Report Number: 3004983210-2015-00004
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: K100562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0030402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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