MAUDE Adverse Event Report: ARTHROSURFACE, INC. CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT; TOE JOINT, PHALANGEAL (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

The patient is experiencing pain and believes joint fusion is his only option.Root cause of the pain was unable to be determined as necessary information to adequately investigate the reported event was not provided.Since the patient received implant more than 10 years ago, it is possible that the arthritis has progressed to the other side of the joint leading to generation of pain.Since no part and lot information was provided, review of the device history records (dhrs) of devices in question cannot be conducted.Arthrosurface advised the patient to visit his implanting surgeon or other surgeons in his network for diagnosis and finding out available options for his pain and other on-going issues.Arthrosurface is following-up with the patient and any additional information obtained from the patient will be reviewed for reportability and submitted via a supplemental mdr.

Event Description

Patient received arthrosurface toe implant 10 years ago and is currently concerned about issues with the bone surrounding the implant.He wants to know if the issues were a result of the surgeon or the device.

• Brand Name: CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
• Type of Device: TOE JOINT, PHALANGEAL (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: 9131797
• MDR Text Key: 162991838
• Report Number: 3004154314-2019-00013
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031859
• 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: 08/29/2019

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: 08/29/2019
• Initial Date FDA Received: 09/27/2019
• 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