MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-14 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[108644182]
No further patient information was provided in response to follow-up communication. The reason for reported issue cannot be ascertained with the information provided by the complainant. The instructions for use (ifu) document states that this type of event can occur and all risks are addressed in the risk documentation. Several factors such as stress/ physical loads on the implants, vascularity of the implantation site, surgical techniques employed during implantation, patient factors (such as age, current state of the immune system, bone quality, and sensitivity to device materials), and patient post-op compliance to rehabilitation procedures etc. , can have impact on the functional effectiveness of the implanted devices. If additional relevant information is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[108644183]
Patient reached out to arthrosurface via website to ask advice regarding her total toe implant which, she received in (b)(6) 2015. Her current physician recommended that she needs to be revised to a graft or fusion as the implant appears to be migrated towards right edge of the left toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00012 |
| MDR Report Key | 7512702 |
| Date Received | 2018-05-14 |
| Date of Report | 2018-04-13 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-14 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | ARTHROSURFACE, INC. |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2018-05-14 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-14 |