MAUDE Adverse Event Report: TORNIER INC. LESSER METATARSAL PHALANGEAL JOINT IMPLANT; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/04/2015

Event Type  Injury  

Event Description

According to information received: "there is an allegation that ms.(b)(6) was injured by a left foot implant on (b)(6) 2014.Ms.(b)(6) was allegedly treated beginning in (b)(6) 2013 for pain and tenderness along the second mpj of her left foot.In (b)(6) 2014, she underwent surgery for the placement of a tornier, inc.Implant on the second mpj of her left foot.Postoperatively, however, she continued to complaint about diffuse pain around the second mpj on the left foot.In (b)(6) 2014, she underwent an mri which reportedly showed bone marrow edema surrounding the prosthesis but no fracture or bone erosion at the site, and it was suspected by her physicians that she had developed a stress injury.Ultimately, a neuroma was removed from her left foot on (b)(6) 2014.On (b)(6) 2014, ms.(b)(6) was admitted for a planned transforaminal epidural steroid injection procedure at fullerton surgical center.The purpose of the injection was to relieve pain in her lower back related to a prior car accident.At the time of the injection, she was wearing an orthopedic boot on her lower left leg as a result of the previous left foot implant surgery, and subsequent surgery to remove the neuroma.Allegedly, she awoke from the injection on (b)(6) 2014 with a headache and significant pain in her surgically repaired left foot.She alleged that the treating doctors damaged her surgically repaired foot while she was under anesthesia.On (b)(6) 2014, she was found to have refractured her left foot, causing hardware loosening of the implant.An expert provided by the surgery center allegedly opined that to a reasonable degree of medical certainty, the foot problems she experienced after injection surgery were not caused by the medical facility.Although it appears that the implant allegedly did become damaged sometime in (b)(6) 2014, there is no evidence per the expert that it was damaged during the (b)(6) procedure.The expert allegedly stated that there were a myriad of ways the implant could have been damaged following is implantation, and that the type of implant she received is "fragile" and "can rupture very easily." he allegedly stated that the implant could have been damaged by normal wear and tear, or by her catching her toe or tripping at any time after it was placed.The location of the product at issue is not known.From reviewing some of the recently available (but limited) records in the companion state court medical malpractice case that it appears plaintiff did have the tornier implant removed on (b)(6) 2014, but the surgeon gave the implant to the plaintiff and she has retained it ever since.There is no indication in those records it was ever sent back to tornier for review and inspection.".

• Brand Name: LESSER METATARSAL PHALANGEAL JOINT IMPLANT
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): TORNIER INC.; 10801 nesbit avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbit ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 5759571
• MDR Text Key: 48468106
• Report Number: 3004983210-2016-00021
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• 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