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

Catalog Number	AR-503-TTTE
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/08/2016
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-ttte and lot number 1297084, 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.Device reported to be discarded.
Event or Problem Description
It was reported by a patient through the arthrex website that the patient had undergone a left tka procedure on (b)(6) 2015.During the procedure the following arthrex parts were implanted: tibial tray-size 4, ar-503-ttte, lot 1297084 ((b)(4)), femoral implant, ar-516-4l, lot 1361640, bearing implant, ar-513-be16, lot 113601331a ((b)(4)) and patella implant, ar-504-psc9, lot 113601437.Patient underwent a revision surgery due to tibial loosening on (b)(6) 2016.Per (b)(6) 2016 revision operative report: the poly bearing implant was removed.The patient's femoral component was evaluated and found to be secure.The interface between the tibial component was disrupted with a osteotome and the tibial component was removed without difficulty.Operative report noted that the component was loose.To complete the procedure a tibial tray - size 3 and an 18 mm poly bearing implant were implanted.Cultures were taken during the revision procedure: gram stain revealed: white blood cells - few, epithelial cells - none observed and bacteria - non observed.Wound culture revealed: no growth.Anaerobic culture revealed: no anaerobes were recovered.

• 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: 6321846
• Report Number: 1220246-2017-00017
• Device Sequence Number: 16317234
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

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: 06/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1297084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/10/2017
• 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: AR-513-BE16, IBALANCE TKA BEARING, LOT 113601331A
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR