MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 6
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/07/2019
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 device history record review for this catalog number, ar-503-tttg and lot number 108761215 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2015 the patient had undergone a bi-lateral tka procedure.On (b)(6) 2019 the patient underwent a revision right tka procedure due to pain and tibial loosening.During the revision procedure the following original arthrex implant devices were explanted: ar-503-tttg, tibial tray implant (lot 108761215); ar-516-7r, femoral implant (lot 108761338); ar-513-bg11, tibial bearing implant (lot 113601405); ar-504-psc9, patella implant (lot 113601430).The revision procedure was completed by implanting another manufacturer's devices.
Additional Manufacturer Narrative
The evaluation revealed the returned device's critical mating feature (top surface a that mates with the poly bearing) are within specifications.The damages observed on the surfaces a and b, as well as the sides of the device were most likely caused during the extraction of the implant.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 6
• 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: 9272291
• Report Number: 1220246-2019-01388
• Device Sequence Number: 1892238
• Product Code: JWH
• UDI-Device Identifier: 00888867106741
• UDI-Public: 00888867106741
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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 6
• Device Catalogue Number: AR-503-TTTG
• Device Lot Number: 108761215
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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
• Patient Age: 60 YR