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

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

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

A definitive root cause cannot be determined with the information provided.The device history records were reviewed indicating the devices were manufactured, inspected and packaged to specification.Since the patient started to feel pain 3 years after surgery, it is possible that the arthritis may have progressed to the other side of the joint.No other complaints or reports concerning pain or other adverse events were reported for the part lots in question.As requested by the patient, local surgeon information was provided for obtaining a secondary opinion.The following is the lot info of implant components received by the patient.Pn: 9095-0018-w lot: 75ek0313 mfg.Date: 05/2011 exp.Date: 05/2016; pn: 9m52-2535-w lot: 75dk0534 mfg.Date: 04/2011 exp.Date: 04/2016.Any further information received from the patient will be documented in the complaint file and reviewed for reporting through a supplemental mdr.

Event Description

Patient received a toe df implant in (b)(6) 2011 and started to feel pain after 3 years of implantation.On consulting a new podiatrist, she was told her only option is to fuse the mtp joint.The patient is currently experiencing excruciating pain and wants to know if implantation of a phalangeal component would help.

• Brand Name: CAP GREAT TOE 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: 8485160
• MDR Text Key: 141014098
• Report Number: 3004154314-2019-00001
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/04/2019
• 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