MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-09 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[129791761]
The reason for reported pain could be due to loosened phalangeal component that was noted during the revision surgery. Root cause for loosening was unable to be determined as the device was not returned and necessary information to adequately investigate the reported event was not provided. Since no part and lot information was provided, review of the device history records (dhrs) of devices in question cannot be conducted. 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. The implant materials and combinations have decades of history for use in joint replacement applications. Also, the implant materials have been evaluated for biocompatibility to demonstrate safety for intended use. If additional relevant information is received, a follow-up report will be submitted. The patient was revised to a fusion and all toemotion components have been explanted. Should arthrosurface receive any further information regarding this event in future, it will be documented and reported accordingly through a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
[129791762]
Arthrosurface ws notified that a patient was revised due to pain. During the revision surgery, loosening of the toemotion phalangeal fixation component was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00020 |
| MDR Report Key | 8145113 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-09 |
| Date of Report | 2018-11-09 |
| Date Mfgr Received | 2018-11-09 |
| Date Added to Maude | 2018-12-09 |
| 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 | 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 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2018-12-09 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-09 |