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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The reason for reported pain could be due to loosened phalangeal component that was noted during the revision surgery.Root cause for loosening 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.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 use.If additional relevant information is received, a follow-up report will be submitted.The patient was revised to a fusion and all toemotion components have been explanted.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 ws notified that a patient was revised due to pain.During the revision surgery, loosening of the toemotion phalangeal fixation component was noted.

• 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: 8145113
• MDR Text Key: 129791761
• Report Number: 3004154314-2018-00020
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• 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