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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The patient inquired if other patients undergo a physical therapy following the hemicap surgery and she is also concerned about not being able to wear heels even after 5 months out.The reason for patient's complaint cannot be ascertained due to lack of information required for the investigation.Since no device or lot information was provided, 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 provided a post-op protocol and was advised to consult their treating surgeon for further concerns regarding implant and physical therapy.The complaint will be closed at this time and any new information received will be reviewed and reported accordingly.

Event Description

The patient reached out to arthrosurface via website to inquire regarding physical therapy after receiving the hemicap.She received the implant five months ago and currently cannot wear heels.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY
• Type of Device: TOE HEMICAP
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin, ma,
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton, ma,
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, ma, ; 5203003
• MDR Report Key: 10022814
• MDR Text Key: 189841394
• Report Number: 3004154314-2020-00002
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• 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
• Patient Outcome(s): Other