MAUDE Adverse Event Report: ARTHROSURFACE, INC. ARTHROSURFACE TOEMOTION; ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ARTHROSURFACE TOEMOTION
• Type of Device: ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 7512702
• MDR Text Key: 108644182
• Report Number: 3004154314-2018-00012
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other