MAUDE Adverse Event Report: TORNIER, INC. PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT); TOE PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/24/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On or about (b)(6) 2007 (b)(6) (the patient) presented to (b)(6) centers and dr.(b)(6) for treatment and evaluation of her right foot pain.Sometime prior to (b)(6) 2011 (b)(6) developed osteoarthritis in her right foot.On or about (b)(6) 2011 dr.(b)(6) recommended that (b)(6) undergo an austin bunionectomy with possible first metatarsal phalangeal joint implant - right foot using the product.On or about (b)(6) 2011 (b)(6) was admitted to (b)(6) for performance of the surgical procedure by dr.(b)(6).On or about (b)(6) 2011 dr.(b)(6) performed the surgical procedure on (b)(6) at (b)(6) and implanted the fgt implant into (b)(6) right foot.On or about (b)(6) 2013 janet presented to (b)(6) centers and dr.(b)(6) for post-operative follow up care of her right foot and complained of right foot pain at the top of her first metatarsal phalangeal joint since (b)(6) 2013.At this time dr.(b)(6) conducted a physical examination of (b)(6) right foot, ordered and reviewed x-rays of (b)(6) right foot and interpreted said x-rays as indicating a possible fracture of the bone in (b)(6) right foot around the product.On or about (b)(6) 2013 (b)(6) presented to the offices of (b)(6) centers and dr.(b)(6) for post operative follow up care with continuing complaints of right foot plain, she was seen and examined by dr.(b)(6) and dr.(b)(6) recommended that (b)(6) undergo a bony resection around the product with possible replacement of the product (a second surgical procedure).On or about (b)(6) 2013 (b)(6) was admitted to (b)(6) for the performance of a second surgery by dr.(b)(6).On (b)(6) 2013 dr.(b)(6) performed the second surgery on (b)(6) and removed the product and replaced it with another futura primus flexible great toe implant (this incident has already been reported to the fda under mdr number 3004983210-2013-00021) on (b)(6) 2014 (b)(6) presented to (b)(6) complaining of right foot pain.On or about (b)(6) 2014 dr.(b)(6) surgically removed the product and performed a fusion of (b)(6) first matatarsalphalangeal joint with plates and screws (a third surgery, and the second time (b)(6) had the original surgery revised).

Manufacturer Narrative

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

• Brand Name: PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT)
• Type of Device: TOE PROSTHESIS
• Manufacturer (Section D): TORNIER, INC.; 10801 nesbitt ave south; bloomington MN 55437
• Manufacturer (Section G): TORNIER, INC; 10801 nesbitt ave south; bloomington MN 55437
• Manufacturer Contact: kevin smith ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5085203
• MDR Text Key: 26113107
• Report Number: 3004983210-2015-00038
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• 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