MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY; MTP HEMI-TOE PROSTHESIS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

Three attempts were made to contact the patient by arthosurface regional manager in her area.No response was received.An investigation cannot be conducted as patient's clinical history or her implant information is currently unavailable.Should any additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

The patient reached out to arthrosurface via website to inquire about list of surgeons in her area.Per initial information relayed to arthrosurface, she received an arthrosurface toe implant in (b)(6) 2017 and since has been experiencing pain and swelling in the joint.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY
• 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: 6865194
• MDR Text Key: 86146375
• Report Number: 3004154314-2017-00019
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131377
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability