MAUDE Adverse Event Report: ARTHREX, INC. ANATOEMIC, 20 MM; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Catalog Number AR-9500-200

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Rash (2033); Swelling (2091); Reaction (2414)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that a rash was first noted on the patient's foot near the implants on both toes and under the foot.The rash then traveled to both her hands.Follow-up information: the patient is having a reaction after an anatomic procedure of the 2nd and 3rd toes of her left foot.A rash was first noted on the patient's foot near the implants on both toes and under the foot.The blistering rash then traveled to both of her hands and wrist.The areas of the rash are red, painful and swollen.The patient had a basic allergy test done and was negative.She will now have a heavy metal patch test performed.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but part remains in the patient and cannot be returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Based on the information provided, the most likely cause(s) of this event is an adverse reaction of the patient to the material(s) implanted.Product directions for use warns of adverse effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.This is the first complaint of this type for this part/lot combination.If additional relevant information is received, a follow-up report will be submitted.Part remains in patient.

• Brand Name: ANATOEMIC, 20 MM
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4148017
• MDR Text Key: 4916677
• Report Number: 1220246-2014-00183
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: AR-9500-200
• Device Lot Number: 1248011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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