MAUDE Adverse Event Report: ARTHREX INC. IBALANCE TKA TIBIAL TRAY SIZE 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTH
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/10/2017
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 1337234 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 underwent a left total knee arthroscopy on (b)(6) 2015.The following was implanted: ar-503-ttth / lot 1337234, ar-504-psc9 / lot 113601511, ar-516-7l / lot 1373719, ar-513-bh10 / lot 113601408.The patient is about 20 months post-op and is experiencing tibial loosening.The revision surgery is currently pending.Patient is a male, (b)(6) weighing (b)(6) pounds.(b)(6).Follow-up investigation: revision surgery took place on (b)(6) 2017.All of the arthrex knee components were explanted and another manufacturer's product was used to complete the revision surgery.Rep had requested that the facility retain the explanted devices for return however they were accidentally discarded at the facility.The revision surgery was performed by a different surgeon than the original surgery.The two surgeries were performed at different facilities.While reviewing x-rays prior to the revision the surgeon had stated to the sales rep that the tibial implant looked as though it was placed in varus, which surgeon believed was the reasoning for the implants loosening.

• 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: 7123154
• Report Number: 1220246-2017-00463
• Device Sequence Number: 2145083
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 07/01/2019
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 1337234
• 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: 11/20/2017
• Initial Report FDA Received Date: 12/15/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 102