MAUDE Adverse Event Report: ARTHROSURFACE, INC. CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT; TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The patient has been advised to contact the regulatory department if she believes there are deficiencies concerning quality, safety, durability, reliability, effectiveness or performance of the device.No response has been received as of the reported date.However, based on the information provided by the patient, the pain could be related to pre-existing conditions such as scar tissue and plantar fascitis and/or other related factors.There are many factors such as patient selection criteria, operating technique, compliance to post-op rehabilitation technique etc, that contribute to the successful outcome of the surgery.There is no clinical evidence indicating the failure of arthrosurface implant or its contribution to the reported issues.The lot number of the device was not provided, without which the dhr or performance history review is not possible.The patient is currently pursuing further treatment with alternative options from her current surgeon.The complaint is considered closed.Should arthrosurface receive additional information regarding this complaint, a supplemental mdr will be filed accordingly.

Event Description

Patient reached out to arthrosurface via website and expressed dissatisfaction over arthrosurface implant as her treating physician is going to fuse her joint.The patient stated she has a toe hemicap implanted 2 years ago and since, has not received adequate pain relief.Following implantation of hemicap, she underwent 2 additional surgeries to remove scar tissue which did not help with pain relief.The patient also stated that she has plantar fascitis (in both feet) which is causing additional pain in her arches and ankles.She also developed a baker's cyst from uneven walking.Patient is concerned that she cannot wear stilettos or shoes due to a big lump on the side of her toe.

• Brand Name: CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
• Type of Device: TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS
• 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: 6588080
• MDR Text Key: 75871098
• Report Number: 3004154314-2017-00006
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K031859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2017
• 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