MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-02 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[122374741]
The patient received toe-motion implant in (b)(6) 2017. Per the rep who attended the revision case, the reported pain, swelling and loss of range of motion were attributed to the loosening of phalangeal component. Root cause was unable to be determined as the device was not returned. The device history records (dhrs) of the implant lots in questions 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-w, lot # 75af2810, mfg. Date: 05/06/2016, exp. Date: 05/06/2021. Part # 9p15-pb01-w, lot # 75cf3110, mfg. Date: 05/11/2016, exp. Date: 05/06/2023.
Patient Sequence No: 1, Text Type: N, H10
[122374742]
A total toe patient was revised due to pain, swelling and loss of range of motion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00017 |
| MDR Report Key | 7927315 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-03 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| 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 | 2018-10-02 |