MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 7
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2014
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-ttth and lot number 780842 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 by the patient¿s legal representative that the patient underwent a right total knee procedure on (b)(6) 2014, and is experiencing unknown issues with the knee replacement.The following arthrex product was implanted during the primary procedure: ar-503-ttth (lot: 780842), ar-516-7r (lot: 108761412) x 2, ar-513-bh10 (lot: 113601339), ar-504-psd0 (lot: 113601323).To date no revision has been reported.The patient also had a left total knee procedure on (b)(6) 2014 which was revised on (b)(6) 2019 (see case (b)(4)).Additional information received on 4/26/2021: arthrex has received confirmation that the patient's right knee was revised on (b)(6) 2021.No additional details pertaining to the revision surgery have been provided.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 7
• 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: 11841119
• Report Number: 1220246-2021-03080
• Device Sequence Number: 17080641
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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 7
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 780842
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• 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: 57 YR