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 Codes	Fall (1848); Failure of Implant (1924)
Date of Event	08/24/2017
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-ttth and lot number 1337230, 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 that the patient had undergone a left total knee replacement procedure on (b)(6) 2015.The patient's post operative follow up records note that the patient reported a fall (landing on both knees) within six weeks following surgery.The records also indicate that the patient had many fall after that; "too many to count" and that the patient is morbidly obese (bmi 40+ pre and post surgery) which is contraindicated for this device.Due to tibial loosening the patient underwent a left total knee revision procedure on (b)(6) 2017.Op report for the (b)(6) 2017 procedure noted that tibial component was loose.During the revision the following arthrex implants were explanted: ar-503-ttth tibial implant (lot 1337230), ar-516-7l femoral implant (lot 1528146), ar-513-bh11 bearing implant (lot 113601340) and ar-504-psd0 patella implant (lot 113901439).To complete the revision procedure the surgeon used another manufacturer's product.

• 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: 8001589
• Report Number: 1220246-2018-00711
• Device Sequence Number: 19157984
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: 07/31/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 7
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 1337230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/24/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 131