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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

Arthrosurface has limited information regarding this case from the source document received.The device was not returned for investigation.As no part number and lot number were provided, the manufacturing history of implant device(s) installed in the patient could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.If additional information becomes available, a supplemental mdr will be submitted.

Event Description

Arthrosurface was notified of the information that a patient implanted with toe hemicap underwent revision surgery on (b)(6) 2017 due to chronic pain in his toe.

• 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: 6810712
• MDR Text Key: 83249537
• Report Number: 3004154314-2017-00011
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/26/2017

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/22/2017
• 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