MAUDE Adverse Event Report: TORNIER INC. FUTURA GREAT TOE; FLEXIBLE GREAT TOE IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 04/01/2013

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.Report based on literature: a retrospective review of the primus first mtp joint double-stemmed silicone implant.Lawrence br, thuen e.Foot ankle spec.2013 apr;6(2):94-100.Doi: 10.1177/1938640012470715 http://www.Ncbi.Nlm.Nih.Gov/pubmed/23291555.

Event Description

As stated in the abstract of the article: "implant arthroplasty has been a surgical alternative for correction of hallux rigidus for many decades.A study is presented reviewing the authors' experience using the (tornier/futura) primus double-stemmed silicone implant.A total of 144 patients representing 201 implants were identified and invited to participate in the study.The postoperative period ranged from 32 to 108 months, with an average of 66.4 months.Chart review was performed on all cases.This review revealed that there were 2 implants that had been removed, each for reasons other than implant breakdown.Several indications in addition to hallux rigidus were found, including hallux valgus with arthritis, geriatric bunion, rheumatoid arthritis, and iatrogenic and traumatic arthritis.The outcomes are presented for all patients, with additional breakdown by their indication for surgery.In all, 54 patients involving 70 implants responded and were clinically evaluated.This study included a visual analogue scale, foot and ankle (vas fa) patient outcome and satisfaction questionnaire, clinical examination, and x-ray evaluation.Patients with hallux rigidus had an average postoperative american orthopaedic foot and ankle society (aofas) score of 88.2, and those with hallux valgus with arthritis had an average score of 88.6.The average aofas score for all patients was 87.4.The average vas patient satisfaction for all patients was 8.5 (with 10 being highest satisfaction).Implant arthroplasty continues to be a viable alternative for surgical correction of hallux rigidus as well as other degenerative conditions of the first mtp joint.This procedure is particularly effective in older, less-active patients with lower functional demand.".

• Brand Name: FUTURA GREAT TOE
• Type of Device: FLEXIBLE GREAT TOE IMPLANT
• 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: 5268301
• MDR Text Key: 32739084
• Report Number: 3004983210-2015-00074
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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: 12/02/2014
• 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