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

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 8
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/02/2018
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 device history record review for this catalog number, ar-503-tttj and lot number 108761234 combination found no related information.
Event or Problem Description
It was reported via the patient's legal representative that the patient had undergone a right total knee arthroplasty on (b)(6) 2014.During the procedure the following arthrex products were implanted: ar-503-tttj, tibial implant, lot 108761234.Ar-503-psrj, femoral implant, lot 108761219.Ar-503-bj12, bearing implant, lot 113601230.Ar-504-psd0, patella implant, lot 113601225.The patient underwent a revision right total knee arthroplasty on (b)(6) 2018 due to painful, loose right total knee arthroplasty.During the procedure the arthrex implants were removed and another manufacturer's products were implanted.The revision operative report findings noted that the tibial and patellar components were grossly loose and the femoral component was poorly fixed.The index and revision surgeries were performed by different surgeons at different locations.The explanted devices were not returned for inspection and the disposition is unknown at this time.

• 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: 8748838
• Report Number: 1220246-2019-01188
• Device Sequence Number: 1690371
• Product Code: JWH
• UDI-Device Identifier: 00888867106765
• UDI-Public: 00888867106765
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 11/30/2017
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 8
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 108761234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR