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

Device Problem Insufficient Information (3190)

Patient Problems Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Date 04/07/2014

Event Type  No Answer Provided  

Manufacturer Narrative

The patient reported pain and swelling through company website.Attempts have been made to contact the patient and there has been no reply from the patient since then.No further actions will be taken at this time.A supplemental report shall be filed if the patient responds back with additional information.

Event Description

Patient contacted to report ongoing pain and swelling in joint since surgery with the implant in (b)(6) 2008.This mdr (fda medwatch form 3500a) is now being filed in accordance with the findings on form 483 (observations), received during our fda inspection held in (b)(6) 2015.

• Brand Name: HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5225518
• MDR Text Key: 31256568
• Report Number: 3004154314-2014-00003
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K131377
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other