MAUDE Adverse Event Report: ARTHROSURFACE HEMICAP TOE IMPLANT; HEMICAP TOE RESURFACING SYSTEM

Model Number 9M52-2545

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 08/09/2013

Event Type  Injury  

Event Description

Initial surgery was in (b)(6) 2013.Patient had continued pain.On 10/06/2014 was last follow up for ongoing pain.She was treated for orthotics and injection.She indicated that she consulted a second surgeon who recommended and revised her to a toe fusion.She no longer has pain, but is less active.The implanting surgeon mentioned no issues were observed during the initial surgery.We are unaware as to the cause of the continued pain.The patient has since had a toe fusion and indicates no further pain.

Manufacturer Narrative

On 06/02/2016 update - this supplemental mdr is being filed to correct the date of surgery (event) as (b)(6) 2013 per the records.It was previously reported as (b)(6) 2013.No other changes.

• Brand Name: HEMICAP TOE IMPLANT
• Type of Device: HEMICAP TOE RESURFACING SYSTEM
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSRUFACE; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: dawn wilson ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5025408
• MDR Text Key: 23933583
• Report Number: 3004154314-2015-00001
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/30/2020
• Device Model Number: 9M52-2545
• Device Lot Number: 75CC0605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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