MAUDE Adverse Event Report: ARTHREX INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-513-T5
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); No Code Available (3191)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of four submissions from the same incident, the others are: (b)(4)-line 235355-00206; (b)(4)-line 235357-00207 and (b)(4)-line 235358-00208.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 information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-513-t5 and lot number 10034400 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2015 the patient underwent a left tka procedure.On (b)(6) 2016 the surgeon performed a revision left tka procedure due to patient pain ((b)(4)/mfr report # 1220246-2016-00295).On (b)(6) 2017, a different surgeon performed a second revision due to instability.During this revision procedure the surgeon explanted the tibial tray ar-513-t5 (lot 1003440), femoral implant ar-516-5l (lot 1482387), bearing implant ar-513-bf-18 (lot 113601335) and patella implant ar-504-psc9 (lot 113601511).The revision was completed using another manufacturers product.Patient female, dob (b)(6).

• Brand Name: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
• 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: 7580277
• Report Number: 1220246-2018-00205
• Device Sequence Number: 2515276
• Product Code: JWH
• UDI-Device Identifier: 00888867187887
• UDI-Public: 00888867187887
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 03/01/2021
• Device Catalogue Number: AR-513-T5
• Device Lot Number: 10034400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/07/2018
• 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: 58 YR