MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[126223425]
The patient received toemotion implant in (b)(6) 2015 and was revised to a fusion in (b)(6) 2018. The reason for reported subsidence is unknown. According to the rep who attended the case, an unknown orange residue was noted in the phalangeal void. Results of the culture are awaited and this report will be supplemented if the results are positive. The root cause was unable to be determined as the device was not returned. The device history records (dhrs) of the implant lots in question were reviewed and noted that all parts were built to specification. Non-conforming parts have been properly identified and segregated during the inspection process. The instructions for use (ifu) document states that reported events can occur, and all risks are addressed in the risk documentation as a apart of the design control. 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, information will be reviewed and complaint file will be amended accordingly. The patient was revised to a fusion and all arthrosurface devices have been explanted. Following is the information of implants in question. Part # 9p15-s180-a lot # 75gd0122 mfg. Date: 07/2014 exp. Date: 07/2019, part # 9p15-pb01-w lot # 75id0208 mfg. Date: 10/2014 exp. Date: 10/2019.
Patient Sequence No: 1, Text Type: N, H10
[126223426]
Arthrosurface was notified of a toemotion revision case where subsidence was noted surrounding the phalangeal component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00019 |
| MDR Report Key | 8002702 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-24 |
| 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 | 2018-10-24 |
| 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 | 2018-10-24 |