MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-01 for PRIMUS FLEXIBLE GREAT TOE IMPLANT FGT-30 manufactured by Tornier Inc.
[3637790]
Device was implanted in 2011 with no grommets. In 2013, the pt returned describing pain around the implant. Pt had good range of motion and showed only a small amount of bone growth. Surgeon went in to clean up bone around implant and noticed that the central hinge appears to have cracked. Device was removed and replaced with the same sized implant. Pt does not have any other health issues and there were no infections or silicone noted in the synovium. Pt is currently doing well.
Patient Sequence No: 1, Text Type: D, B5
[11007473]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2013-00021 |
| MDR Report Key | 3284106 |
| Report Source | 05 |
| Date Received | 2013-08-01 |
| Date of Report | 2013-07-09 |
| Date of Event | 2013-05-15 |
| Date Mfgr Received | 2013-07-09 |
| Date Added to Maude | 2013-10-28 |
| 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 FLEXIBLE GREAT TOE IMPLANT |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2013-08-01 |
| Catalog Number | FGT-30 |
| Lot Number | CT0111229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-01 |