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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032)

Event Date 08/11/2006

Event Type  No Answer Provided  

Manufacturer Narrative

There has been no additional surgeon feedback linking the implant or instruments to the infection.No information was available to further investigate this issue.

Event Description

Surgeon reported that patient had an infection and limited range of motion.

• Brand Name: CAP GREAT TOE 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: 5225480
• MDR Text Key: 31262150
• Report Number: 3004154314-2006-00003
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• 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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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