MAUDE Adverse Event Report: ARTHROSURFACE, INC. ARTHROSURFACE TOEMOTION; ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Loss of Range of Motion (2032); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

There is limited information regarding the patient's history with arthrosurface implants.The patient is currently looking for second opinion referrals and has been redirected to an arthrosurface rm in her area.Any additional information relevant to the patient issues received will be submitted through supplemental mdr's.

Event Description

Patient reached out to arthrosurface via website and complains of restricted movement and tissue damage due to arthrosurface toe implant.The dates of initial and revision surgeries are unknown at this time.

• Brand Name: ARTHROSURFACE TOEMOTION
• Type of Device: ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT
• 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: 6000792
• MDR Text Key: 56537324
• Report Number: 3004154314-2016-00013
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132496
• 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: 09/18/2016

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: Physician
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2016
• Initial Date FDA Received: 10/05/2016
• 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