MAUDE Adverse Event Report: ARTHREX INC. IBALANCE TKA,BEARING IMPLANT,PS,SZ 4,13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-513-BE13
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/12/2016
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 information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-513-be13 and lot number 113601345 combination found no related information.
Event or Problem Description
On (b)(6) 2017 it was reported via the patient's attorney that a patient had undergone a revision tka procedure.It was reported that patient's first issues with the explanted device were instability, pain and motion which arose in (b)(6) 2015.At the time of initial report the following arthrex product was indicated: ar-503-ttte, lot 1206173.Neither the original surgery date or revision surgery date were provided during initial report.Patient date of birth is (b)(6).Additional information received on 10/02/2017: on (b)(6) 2014 patient underwent a bilateral tka procedure.Patient has experienced constant pain since original surgery.On (b)(6) 2016 exam and radiographs were performed.On (b)(6) 2016 surgeon performed a revision right tka due to pain and tibial loosening.During the revision procedure the surgeon explanted the ibalance tka tibial tray, ar-503-ttte, lot 1206173 (line 206787); ibalance patella implant dome, ar-504-psc9, lot 113601411 (line 209438); ibalance tka bearing, ar-513-be13, lot 113601345 (line 209440); and ibalance tka femoral implant, ar-516-4r, lot 108761406 (line 209441).To complete the procedure the surgeon used another manufacturer's product.Patient was a female.Additional information received on 10/9/2017: medical records dated 12/4/2015 notes "that the patient fell off a ladder on (b)(6) 2015 and fractured her right ankle.Patient underwent surgery to repair her right ankle on (b)(6) 2015.Medical records (b)(6) 2016 note a positive (b)(6) test result".Medical records also noted patient had a bmi of approx.(b)(6) which is contraindicated for this device.

• Brand Name: IBALANCE TKA,BEARING IMPLANT,PS,SZ 4,13MM
• 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: 6983256
• Report Number: 1220246-2017-00402
• Device Sequence Number: 10884752
• Product Code: JWH
• UDI-Device Identifier: 00888867107281
• UDI-Public: 00888867107281
• 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: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 01/01/2019
• Device Catalogue Number: AR-513-BE13
• Device Lot Number: 113601345
• 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: 10/02/2017
• Initial Report FDA Received Date: 10/27/2017
• 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