MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2013-03-12 for PRIMUS FUTURA GREAT TOW IMPLANT UNK manufactured by Tornier In..
[17565492]
Metatarsalgia was the most common complication. One foot required weil osteotomy of the second metatarsal.
Patient Sequence No: 1, Text Type: D, B5
[17671158]
(b)(4): lawrence, b. R. , thuen, e. A retrospective review od the primus first mtp joint double-stemmed silicone implant, 2012, journal article page 3. This is the initial report submitted regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2013-00002 |
| MDR Report Key | 3003877 |
| Report Source | 03 |
| Date Received | 2013-03-12 |
| Date of Report | 2013-02-12 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-03-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN SMITH |
| Manufacturer Street | 10801 NESBITT AVE S |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9524267643 |
| Manufacturer G1 | TORNIER, INC. |
| Manufacturer Street | 10801 NESBITT AVE S |
| 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 FUTURA GREAT TOW IMPLANT UNK |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2013-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER IN. |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-12 |