MAUDE Adverse Event Report: ARTHROSURFACE CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY; HEMICAP - PROSTHESIS, TOE, HEMI-, PHALANGEAL

Model Number 9070-0013-W / 9122-2030-W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/12/2013

Event Type  No Answer Provided  

Manufacturer Narrative

The device was explanted by another surgeon and was not returned for evaluation by the manufacturer.It was learned that the patient had an unrelated condition known as tarsel tunnel syndrome, which is an impringment disorder of the tibial nerve in the ankle, which creates radiating pain symptoms throughout the foot.Following revision surgery, it was found that patient had resumed routine daily activities.

Event Description

Patient reported pain and was unsatisfied with the outcome of the procedure.The patient also decided to undergo a revision surgery in which the implant components were explanted.

• Brand Name: CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
• Type of Device: HEMICAP - 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: 5233929
• MDR Text Key: 31547624
• Report Number: 3004154314-2013-00003
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K063370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• 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: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9070-0013-W / 9122-2030-W
• Device Catalogue Number: 9070-0013-W / 9122-2030-W
• Device Lot Number: L75BI0513 / 75AG2308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2013
• 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): Required Intervention