MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; PIN, FIXATION, SMOOTH

Catalog Number AR-1588RT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, weight) were requested but not provided.This is the fifth of four submissions from the same patient event.The others are 1220246-2016-00359 ((b)(4)), 1220246-2016-00360 ((b)(4)),1220246-00361 ((b)(4)) and 1220246-2016-00362 ((b)(4)).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.Lot number was not provided so device history record review cannot be performed.The device was not returned for evaluation but remained in the patient 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.The most likely cause of this type of event is a reaction of the patient to the material(s) implanted.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 device materials must be considered prior to implantation.Device remains in patient.

Event Description

It was reported by the patient on day of the revision procedure, (b)(6) 2016, that she had undergone an acl reconstruction on (b)(6) 2016 on her right leg.On (b)(6) 2016 the patient began to notice extreme swelling, knee was hot to the touch, she had a skin rash with welts and burning in and around the incision.The reaction also spread to the lateral side of the femur and tibia.The patient had an er visit on (b)(6) 2016 where bloodwork was taken.Results were negative for infection.Surgeon decided to bring patient in for second surgery and possible removal of the implants.Patient states that prior to the (b)(6) 2016, procedure she had allergy testing which showed that she was allergic to nickel.The following parts were implanted during the original (b)(6) 2016 procedure: ar-1934bcf lot 1240957 ((b)(4)), ar-1934bcf lot 1240946 ((b)(4)), ar-2324bcc lot 10025466 ((b)(4)) and ar-5035tc-09 lot 1314851 ((b)(4)).Additional information was obtained on (b)(6) 2016 as follows: the patient's mother called to report that during a surgeon visit while they were going over the material composition of the patients implants listed on the facility implant log the surgeon informed them that there was an additional part that was used for the patient's surgery that he noticed the or staff did not include on the patient's implant log.The missing part number provided to the patient by the surgeon was ar-1588rt, acl tightrope rt with titanium and uhmwpe.

• Brand Name: ACL TIGHTROPE RT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6030707
• MDR Text Key: 57553406
• Report Number: 1220246-2016-00428
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019553
• UDI-Public: 00888867019553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-1588RT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• 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