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 Loss of Range of Motion (2032); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The mtp hemicap device remains implanted in the patient and therefore will not be returned, therefore no product evaluation is conducted.No x-rays, scans, pictures, physician's reports etc., were provided.Current information is insufficient to permit a valid conclusion about the cause of the reported issues.A review of device history record (dhr) review was not conducted as part and lot number of the devices involved are unknown.However, according to the patient's surgeon, the reported issues may be related to patient condition.The outcome of a surgery depends on several factors such as patient's bone quality, surgical operating technique, compliance to post-operative rehabilitation etc., if any further information is found which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly.

Event Description

The patient reached out to arthrosurface via website to inquire about pain and loss of range of motion she is currently experiencing.She received an arthrosurface mtp hemicap device in (b)(6) 2017 and is undergoing pt per surgeon's recommendation to obtain pain relief from the scar tissue.However, the patient is still having continued pain and concerns about range of motion.During a recent follow-up visit, het treating surgeon told that the pain may be due to the friction between the bones on either side of the joint.

• 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: 6978913
• MDR Text Key: 90283401
• Report Number: 3004154314-2017-00023
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K131377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• 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