MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that he underwent a uni-knee procedure on his right knee on (b)(6) 2013.During the procedure the following arthrex parts were implanted: ar-501-ttrd lot 108761138, ar-501-tbd8 lot 77941146, ar-501-ufrd lot 108761138.Approximately 4-6 months after the procedure patient began to notice slipping in his knee and a strong stabbing pain that eventually became unbearable.Patient underwent a revision procedure (b)(6) 2015 from a uni-knee to a total-knee.During the revision procedure all arthrex implants were explanted and another manufacturer's product was used to complete the revision.The patient had obtained the explanted devices from the facility.Patient has agreed to send the products to arthrex for evaluation and has requested to receive a copy of the evaluation results.
Additional Manufacturer Narrative
This follow-up is to add information.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

• Brand Name: IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM
• 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: 7638447
• Report Number: 1220246-2018-00528
• Device Sequence Number: 16609730
• Product Code: JWH
• UDI-Device Identifier: 00888867033986
• UDI-Public: 00888867033986
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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 Model Number: IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM
• Device Catalogue Number: AR-501-TBD8
• Device Lot Number: 77941146
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1