MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 4
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	05/09/2018
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 catalog number, ar-503-ttte and lot number 1206173, 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 the patient's attorney that a patient had an original bi-lateral tka procedure on (b)(6) 2014.On (b)(6) 2016 patient underwent a revision right tka (arthrex reference # (b)(4) medwatch 1220246-2017-00400).On (b)(6) 2018 patient underwent a revision left tka during which the original arthrex implants below were explanted: ar-503-ttte, lot 1206173, tibial tray implant; ar-516-4l, lot 108761402, femoral implant; ar-513-be13, lot 113601414, tibial bearing implant; ar-504-psc9, lot 113601411, patella implant.Per arthrex complaint reference (b)(4), medical records dated (b)(6) 2015 note "she had fallen when visiting her daughter (b)(6) and had surgery that night for external rotation of the right fib." medical records also noted patient had a bmi of approx.(b)(6) which is contraindicated for this device.Information obtained from (b)(6) 2018 op report: revision pre and post operative diagnosis was loosening of tibial component.The tibial component was completely loose.There was no aspect of cement that adhered to the tibia component.Alternatively the cement was fixated to the tibia bone.Revision procedure was completed using another manufacturer's tka devices.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 4
• 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: 7841425
• Report Number: 1220246-2018-00615
• Device Sequence Number: 16505262
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 06/30/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 4
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1206173
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR