MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTE
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/19/2017
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 three submissions for the same patient event.The other two submissions are: 1220246-2017-00169 ((b)(4)) and 1220246-2017-00170 ((b)(4)).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-ttte and lot number1315462 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.Unknown device disposition.
Event or Problem Description
It was reported that on (b)(6) 2015 a patient had undergone a tka procedure during which the patella was not resurfaced.On (b)(6) 2017 the surgeon performed a revision tka due to tibial loosening and pain.During the revision the following devices were explanted: tibial tray, ar-503-ttte, lot 1315462, femoral implant, ar-516-5r, lot 108761425 and bearing implant, ar-513-be09, lot 113601402.The revision was completed using another manufacturer's product.The operative reports and medical records indicate patient is morbidly obese (bmi of (b)(6)) which is contraindicated for this product.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 4
• 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: 6581002
• Report Number: 1220246-2017-00168
• Device Sequence Number: 97637
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/22/2017

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: 06/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1315462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/22/2017
• 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: 103