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 patient was suggested to consult her doctor as arthrosurface does not provide medical advice or diagnosis.Based on the information provided, it is possible that the arthritis may have progressed or the scar tissue has built up.The exact cause for reported pain and diminished mobility is unknown.The part and lot information of the device in question are unknown.Hence, a review of the device history record (dhr) cannot be conducted.The package insert of the device states that this type of event(s) can occur and all risks are addressed in the risk documentation.An appropriate root cause was unable to be determined as necessary information to adequately investigate the reported events was not provided.Should arthrosurface receive any additional information 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 and stated she received the toe hemicap 1.5 years ago.According to her, she had the hemicap procedure done to undo a painful fusion.She is happy and can bend the toe a little.However, it is slightly painful, swollen and does not have full motion.She also stated that she developed hallux valgus and asked her doctor if there was a scar tissue build.The doctor is unsure.

• 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: 8760105
• MDR Text Key: 150120560
• Report Number: 3004154314-2019-00006
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2019

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: 05/28/2019
• Initial Date FDA Received: 07/03/2019
• 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