MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTJ
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.This is one of four submissions from the same patient event.The others are 1220246-2017-00028 ((b)(6)), 1220246-2017-00029 ((b)(6)), and 1220246-2017-00030 ((b)(6)).The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The catalog number, ar-503-tttj and lot number 125021, associated with this event has been involved in recall number 1220246-1/29/16-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.
Event or Problem Description
It was reported that on (b)(6) 2015 a patient underwent a left tka procedure.On (b)(6) 2017, the surgeon performed a revision left tka due to unexplained pain and loose tibia.During the revision procedure the surgeon explanted the (tibial tray ar-503-tttj, lot 1251021, ((b)(6)), bearing implant ar-513-bj13, lot 113601404 ((b)(6)), femoral implant ar-516-8l, lot 108761335 ((b)(6)) and patella implant ar-504-psc9, lot 113601437 ((b)(6)).To complete the procedure the surgeon used another manufacturer's product.Patient was a male, dob (b)(6) 1956.Patient was in the obese range by bmi at the time of initial which is contraindicated for tka.Patient medical records dated (b)(6) 2016 noted: left knee x-ray findings - prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.Records noted patient would start weight loss program to see if it would make any difference.Patient medical records date (b)(6) 2016 noted: patient had a i&d of hematoma on (b)(6) 2015.Patient has had embolizations x3, patient was noted to have decreased mobility, pain with sleeping, walking, stairs and all weight bearing activities.Examination of the left knee demonstrated swelling and well healing incision, venous insufficiency leg edema.Palpation of the left knee demonstrated inferior pole patella tenderness as well as both medial and lateral tibial plateau tenderness.Mild effusion of the left knee was noted.Records noted x-rays showed no change since (b)(6) 2016.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 8
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6360421
• Report Number: 1220246-2017-00027
• Device Sequence Number: 42206
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: 05/01/2019
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 1251021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-1/29/16-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 181