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 Problems Loss of Range of Motion (2032); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Arthrosurface has limited knowledge regarding the patient's actual medical background surrounding his toe complications and issues.Patient had multiple surgeries on the first mtp joint in his right foot.Note that the patient's medial sesamoid bone was removed and replaced by a bone tissue transplant.Based on the information provided, the patient apparently had issues prior to the implantation of arthrosurface device.Patient expressed dissatisfaction over hemicap decompression beyond the recommended length and the surgical technique that was carried out.Upon consulting other physicians for a second opinion, patient learned that he has neuropathic (damaged) posterior tibial nerve from earlier surgeries which may be causing pain.There is no discernible evidence that arthrosurface hemicap had actually caused or contributed to any of the reported issues or complications.Several factors including surgical technique, compliance to post-operative rehabilitation techniques, patient selection factors such as age, disease condition etc, contribute to the outcome of the surgery.The patient retains the hemicap device as of the reported date.The lot number of arthrosurface device was not provided without which review of dhr or performance history of the lot in question is not possible.The patient is currently pursuing treatment from an orthopedic physician in his home country.Should arthrosurface receive any additional information regarding this complaint, a supplemental mdr will be filed.

Event Description

On 04/24/2017, the patient emailed his original surgeon, facility staff and arthrosurface regarding his issues/ complications surrounding current & previous implants and related surgeries.The patient obtained treatment in us although being an (b)(6) native.Following are the surgical events related to the patient that were performed by the same surgeon.In (b)(6) 2013, patient received a medial sesamoid transplant (bone tissue supplied by (b)(6)) after having been diagnosed with a damaged sesamoid bone in an injury.Per patient, the transplant failed.This led to pain and other problems in his toe.In (b)(6) 2014 the patient received a hemicap df implant (manufactured by arthrosurface) due to arthritis of the hallux.However, the patient believes that he was never a candidate for hemicap or any other prosthesis procedure.As the patient continued to have pain and could not walk without support, he was re-operated to remove the sesamoid transplant and to reposition the abductor hallucis muscle in (b)(6) 2016.Following the third surgery, the patient returned to (b)(6) and consulted two additional surgeons to address pain and seek further treatment.He learned that his posterior tibial nerve is damaged from a surgery.The patient believes that none of the above stated surgeries helped him restore his original lifestyle.Currently, the patient is concerned about the loss of range of motion, excessive decompression and pain in his operated 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: 6588060
• MDR Text Key: 75871344
• Report Number: 3004154314-2017-00005
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031859
• 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: 04/24/2017

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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• 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