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 Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

On following-up, the patient stated that she did not get x-rays to see if the arthritis progressed.She also stated that both the surgeons felt that her seasmoids were effected which could be the reason for the reported pain.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 social media and stated she received the toe hemicap 2 years ago and since has been in pain.According to her, the original surgeon and second opinion surgeon had suggested using orthotics for pain relief.Orthotics helped but she is still experiencing pain.

• 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: 8760100
• MDR Text Key: 150121844
• Report Number: 3004154314-2019-00005
• 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