MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2015-12-04 for FUTURA GREAT TOE manufactured by Tornier Inc..
[32739084]
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.
Patient Sequence No: 1, Text Type: N, H10
[32739085]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004983210-2015-00074 |
| MDR Report Key | 5268301 |
| Report Source | LITERATURE |
| Date Received | 2015-12-04 |
| Date of Report | 2014-12-02 |
| Date of Event | 2013-04-01 |
| Date Mfgr Received | 2014-12-02 |
| Date Added to Maude | 2015-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DUSTIN SMITH |
| Manufacturer Street | 10801 NESBIT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURA GREAT TOE |
| Generic Name | FLEXIBLE GREAT TOE IMPLANT |
| Product Code | KWH |
| Date Received | 2015-12-04 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-04 |