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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently investigating the issue and will submit the results in a supplemental report.

Event Description

In a patient, bone resorption was noticed behind the toe hemicap implant during revision surgery.

Manufacturer Narrative

The patient was revised to a fusion and the surgeon was satisfied with the outcome.No additional adverse events have been reported from this event.Since no pathology testing was conducted, it is unknown whether a tissue infection was present.Also, the revision surgeon is unaware of patient's sensitivity to metals and no testing was performed in this regard.The cause of the reported event cannot be determined from the information available and without device evaluation.Since the part and lot information is not available, a review of the manufacturing records of devices in question could not be performed.It is possible that the reported bone resorption could be related to an adverse patient reaction to the materials implanted.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, 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 package insert provided with the product states that this type of event can occur.The risk associated with the event has been documented in the design file with appropriate control measures.The implant materials and combinations have decades of history for use in joint replacement applications.Also, the implant materials have been evaluated for biocompatibility to demonstrate safety for intended purposes.If additional relevant information is received, a follow-up report will be submitted.The results of the investigation could not verify or identify any product contribution to the reported event with the information provided.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY
• Type of Device: MTP HEMI-TOE PROSTHESIS
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• MDR Report Key: 7386770
• MDR Text Key: 104027447
• Report Number: 3004154314-2018-00008
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• 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: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR