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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The patient received two arthrosurface toemotion implants bilaterally and implanted one year apart.However, the exact dates are unknown.This report is for the second arthrosurafce toemotion device.The report for the first device is filed under mdr# "3004154314-2018-0013." the reason for reported loosening 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.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.The rep who attended the revision case stated that the patient's bone quality could have been a factor.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 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.

Event Description

Arthrosurface was notified of a revision case where the patient had bilateral toemotion implants loosened.

• 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): PRIMO MEDICAL GROUP; 75 mill st; stoughton MA 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 7683335
• MDR Text Key: 114154385
• Report Number: 3004154314-2018-00014
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/12/2018
• 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