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	08/14/2018
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 1380224 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 has been reported on october 4, 2018 by the patient's legal representative that patient had undergone a left tka procedure on (b)(6) 2015 and a right tka procedure on (b)(6) 2015.Specific information regarding the patient's issues have not been provided.No revision procedures have taken place that arthrex is aware of.The following arthrex devices were implanted during the left tka on (b)(6) 2015: tibial tray implant, ar-503-ttth, lot 1358298, femoral implant, ar-517-7l, lot 1438515, bearing implant, ar-513-rh, lot 113601428.The following arthrex devices were implanted during the right tka on (b)(6) 2015: tibial tray implant, ar-503-tttf, lot 1380224, femoral implant, ar-517-7r, lot 1738528, bearing implant, ar-512-rf08, lot 113601434, patella implant, ar-504-psc9, lot 113601527.Additional information provided 2/4/2019: medical records dated (b)(6) 2017 noted the right knee has varus malalignment with subsidence and loosening.It was also recommended that the patient lose weight as his bmi was closer to 46.On (b)(6) 2018 the patient underwent a revision right tka due to tibial loosening.During the revision procedure the right tibial tray, femoral implant, bearing implant and patella implant were all explanted.The devices were replaced with another manufacturer's product.The revision took place at a different facility then the original right tka surgery and was performed by a different surgeon.At the time of the revision the patient's bmi was 37.

• 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: 8381860
• Report Number: 1220246-2019-00925
• Device Sequence Number: 2326554
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 09/30/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 5
• Device Catalogue Number: AR-503-TTTF
• Device Lot Number: 1380224
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BEARING IMPLANT AR-512-RF08, LOT 113601434; FEMORAL IMPLANT AR-517-7R, LOT 1738528; PATELLA IMPLANT AR-504-PSC9, LOT 113601527
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 113