MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-17 for PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT) manufactured by Tornier, Inc..
[26113107]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
[26113148]
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).
Patient Sequence No: 1, Text Type: D, B5
[33409098]
This is the final report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2015-00038 |
| MDR Report Key | 5085203 |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-16 |
| Date of Event | 2014-08-24 |
| Date Mfgr Received | 2015-09-16 |
| Date Added to Maude | 2015-09-17 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEVIN SMITH |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Manufacturer G1 | TORNIER, INC |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT) |
| Generic Name | TOE PROSTHESIS |
| Product Code | KWH |
| Date Received | 2015-09-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER, INC. |
| Manufacturer Address | 10801 NESBITT AVE SOUTH BLOOMINGTON MN 55437 US 55437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-17 |