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

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

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

Event Type  Injury  

Manufacturer Narrative

The exact cause for the patient's issues is unknown.The mtp hemicap device remains implanted in the patient and will not be returned.Therefore no product evaluation is conducted.No x-rays, scans, pictures, physician's reports etc.,were provided.Patient is currently seeking a second opinion with a surgeon referred by arthrosurface.Should 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 complain that she continues to have pain and swelling after receiving hemicap.

• Brand Name: HEMICAP® MTP 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: 7146780
• MDR Text Key: 95791770
• Report Number: 3004154314-2017-00028
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• 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: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1