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 Code	Pain (1994)
Date of Event	11/13/2019
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-ttth and lot number 1358298, 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 by the patient that he had total knee reconstruction on (b)(6) 2015.About two years ago the patient started experiencing pain in the knee.Per the patient, x-rays were taken and it was determined the knee is now loose.Patient is scheduled for a revision left tka surgery on (b)(6) 2019.Additional information obtained 10/10/2019: the patient had undergone a bi-lateral tka procedure on (b)(6) 2015.Patient reported that bone scans were taken which confirmed his left tibial implant to be loose.Patient stated he has dealt with the pain and accompanying issues for over two years, taking 1000 mg of tylenol and 800 mg of ibuprofen daily over past several years, but reports his leg is now bowed and causing sciatica type pain in his hip.During the (b)(6) 2015 original procedure the patient had the following arthrex devices were implanted in his left knee: ar-503-ttth, tibial tray implant (lot 1358298), ar-516-7l, femoral implant (lot 1373719), ar-513-bh12, bearing implant (lot 113601409), ar-504-psd0, patella implant (lot 113601430).Additional information obtained 11/19/2019: confirmation was received that the patient's left tka revision procedure took place as scheduled on (b)(6) 2019.All original left tka components were explanted and another manufacturer's product was used to complete the procedure.The explanted devices were retained by the patient.

• 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: 9457411
• Report Number: 1220246-2019-01477
• Device Sequence Number: 16913397
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: 07/31/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 7
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 1358298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 12/12/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR