MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT; MTP HEMI-TOE PROSTHESIS

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Type  Injury  

Manufacturer Narrative

The patient had 2 failed surgeries prior to receiving arthrosurface toe hemicap implant in (b)(6) 2016.After the surgery, she never got more than 15° of dorsiflexion and is experiencing pain in the joint area.The reason for reported issues cannot be ascertained due to availability of limited information.Without part and lot information of the device(s) implanted, an investigation of the device history or performance cannot be conducted.There is no reasonable evidence from the information provided that arthrosurface device(s) had contributed to the reported pain and loss of motion.Arthrosurface has directed the patient to our website for additional physician information in case another opinion is desired.Any additional information received regarding this complaint will be reported through a supplemental mdr as necessary.

Event Description

Patient reached out to arthrosurface via website to inquire if arthrosurface toemotion is an option after a failed hemicap.The patient stated that she never had adequate range of motion (rom) and currently experiencing pain.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
• Type of Device: MTP HEMI-TOE 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: 7311222
• MDR Text Key: 101465660
• Report Number: 3004154314-2018-00005
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• 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