MAUDE Adverse Event Report: ARTHREX INC. ANATOEMIC, 18.5MM; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Catalog Number	AR-9500-185
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, 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.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient was having severe pain and swelling in her right foot and on (b)(6) 2017, an anatoemic prosthesis surgery was performed and an ar-9500-185, anatoemic prosthesis 18.5mm was implanted (lot 1410007).Patient stated she had also had a prior bunion surgery on that same foot approximately 20 years ago.Patient states that her right foot continues to swell on a daily basis and is causing her significant pain.She is unable to wear a normal shoe due to the swelling and pain.Patient states she has no known allergies to metals but does have allergies to many antibiotics and many medications make her very ill.No infection or allergy testing has been done as of time of report.Patient has seen her surgeon, who in her opinion has been dismissing her symptoms and her.Patient was calling to inquire if arthrex could determine if the device size might have been wrong for her foot.Patient was informed that arthrex is not qualified to make that determination as only a licensed medical professional can do so.Patient was referred back to her regular surgeon or a different surgeon for a second opinion.Patient was also provided with the material composition of the device to provide if needed when obtaining a second opinion.Device is comprised of cobalt chrome follow-up investigation: arthrex device ar-9500-185 was the only implant the patient received during the (b)(6) 2017 procedure.

• Brand Name: ANATOEMIC, 18.5MM
• Common Device Name: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7048078
• Report Number: 1220246-2017-00446
• Device Sequence Number: 13845804
• Product Code: KWD
• UDI-Device Identifier: 00888867060616
• UDI-Public: 00888867060616
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: AR-9500-185
• Device Lot Number: 1410007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other