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 TOE IMPLANT UNK manufactured by Tornier, Inc..
[21754418]
Metatarsalgia was the most common complication. One foot required weil osteotomy of the second metatarsal.
Patient Sequence No: 1, Text Type: D, B5
[21908807]
Lawrence, b. R. , thuen, e. A retrospective review of the primus first mtp joint double-stemmed silicone implant, 2012, journal article page 3. This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2013-00003 |
| MDR Report Key | 3003876 |
| 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 | 9824267643 |
| 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 TOE 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, INC. |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-12 |