MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[106852359]
The reason for reported event is unknown. Root cause was unable to be determined as the device was not returned and necessary information to adequately investigate the reported event was not provided. The device history records (dhr) of the component lots in question were reviewed and noted that the product was built to specification and no non-conformances relative to the issue were documented. The instructions for use (ifu) document states that this type of event(s) can occur and all risks are addressed in the risk documentation. The rep who attended the revision case stated that the explanted device looked good and did not notice any issues with it. 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 purposes. If additional relevant information is received, a follow-up report will be submitted. The results of the investigation could not verify or identify any product contribution to the reported event with the information provided. The patient was revised to a new set of toemotion components and the surgeon was satisfied with the outcome. Should arthrosurface receive any further information regarding this event in future, it will be documented and reported accordingly through a supplemental mdr. The part, lot and shelf-life information of the explanted components are as follows: part # 9p15-pb01-w lot # 75de0121-r mfg. Dt 04/01/2015 exp. Dt 04/01/2022. Part # 9p15-s180-w lot # 75ke0507 mfg. Dt 11/08/2015 exp. Dt 11/08/2020.
Patient Sequence No: 1, Text Type: N, H10
[106852360]
Arthrosurface was notified of an event where the phalangeal components of the toemotion implant radiographically appear to be loosened in a patient due to bone resorption.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00009 |
| MDR Report Key | 7446445 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-03-21 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-04-20 |
| 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 | 0 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2018-04-20 |
| 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 | 2018-04-20 |