MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 3
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/11/2016
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-tttd and lot number 780838 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 via patient legal representative that a patient had undergone a left total knee replacement procedure on (b)(6) 2014.During the 2014 procedure the following devices were implanted: ar-503-tttd (lot 780838) tibial tray implant; ar-516-5l (lot 1279940) femoral implant; ar-513-bd12 (lot 113601329) tibial bearing implant; ar-504-psc9 (lot 113601411) patella implant.On (b)(6) 2016 the patient underwent a revision left tka procedure due to loosening of the left total knee.During the revision procedure all arthrex implants from the (b)(6) 2014 procedure were explanted.The surgery was completed by implanting another manufacturer's product.Additional information received on 5/29/2019: it was reported in the patient's medical records dated (b)(6) 2014 that the patient fell directly on her knee two weeks prior to the follow up appointment.Medical records dated (b)(6) 2015 note that the patient was doing fair and functionally the left knee is doing well but she has had multiple falls for unknown causes.Surgeon discussed that her falls play a significant role in her recovery.Additional medical records dated (b)(6) 2015 note that the patient's bone scan was positive for loosening of the prosthesis.Patient had a bmi of approximately 40 at the time of the index surgery and revision surgeries.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 3
• 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: 8711104
• Report Number: 1220246-2019-01150
• Device Sequence Number: 2662941
• Product Code: JWH
• UDI-Device Identifier: 00888867106710
• UDI-Public: 00888867106710
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 10/31/2018
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 3
• Device Catalogue Number: AR-503-TTTD
• Device Lot Number: 780838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/19/2019
• 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: 64 YR
• Patient Weight: 105