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	No Information (3190)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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-tttf and lot number 971202 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 the patient had undergone a right total knee arthroplasty on (b)(6) 2014.During the 2014 procedure the patella was not resurfaced and the following arthrex products were implanted: tibial tray, ar-503-tttf, (lot 971202); femoral implant, ar-503-psrf, (lot 108761207); bearing implant, ar-503-bf12, (lot 113601237).On (b)(6) 2019 the patient underwent a revision right tka procedure.Additional information provided (b)(6) 2019: revision was due to tibial loosening.All original 2014 devices were explanted during the revision.The revision was completed using another manufacturer's products.The devices will not be returning for evaluation as it was reported by the sales rep that returning the devices is against hospital policy.

• 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: 8964735
• Report Number: 1220246-2019-01298
• Device Sequence Number: 16774399
• Product Code: JWH
• UDI-Device Identifier: 00888867106734
• UDI-Public: 00888867106734
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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 Model Number: IBALANCE TKA TIBIAL TRAY SIZE 5
• Device Catalogue Number: AR-503-TTTF
• Device Lot Number: 971202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/05/2019
• 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: 59 YR