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

According to the patient, the surgeon recommended stretching the toe joint but that did not help.The reason for patient's pain cannot be ascertained due to lack of information required for the investigation.Since no device or lot information is unavailable, a review of device manufacturing records could not be conducted.Several factors such as stress/ physical loads on the implants, vascularity of the implantation site, surgical techniques employed during implantation, patient factors (such as age, pre-existing conditions, current state of the immune system, bone quality, and sensitivity to device materials), and patient post-op compliance to rehabilitation procedures etc.Can have impact on the functional effectiveness of the implanted devices.The patient was advised to consult their treating surgeon for further evaluation of the reported pain.The complaint will be closed at this time and any new information received will be reviewed and reported accordingly.

Event Description

Patient received toe hemicap in (b)(6) 2020.Currently patient is experiencing sharp pain at the bottom of the toe 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: 11389433
• MDR Text Key: 233968047
• Report Number: 3004154314-2021-00001
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 01/30/2021
• 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
• Patient Outcome(s): Other