MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 5
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/26/2018
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.The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number ar-503-tttf and lot number 108761213 combination found no related information.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to a loose tibial tray after having a total knee replacement done on (b)(6) 2015.The following arthrex parts were implanted during the original total knee replacement.Ar-503-tttf / lot: 108761213, ar-516-5l / lot: 1252985, ar-513-bf14 / lot: 113601343, ar-504-psd0 / lot: 113601430.The rep confirmed that all arthrex parts that were implanted during the original surgery, were explanted during the (b)(6) 2018 revision surgery.The revision surgery took place at the same facility and was performed by the same surgeon who performed the initial procedure.Sales rep was present during the original and revision surgery.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 5
• 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: 8221879
• Report Number: 1220246-2019-00834
• Device Sequence Number: 16209118
• Product Code: JWH
• UDI-Device Identifier: 00888867106734
• UDI-Public: 00888867106734
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: 12/31/2017
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 5
• Device Catalogue Number: AR-503-TTTF
• Device Lot Number: 108761213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/07/2019
• 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