MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY, SIZE 2; PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/

Catalog Number	AR-503-TTTC
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/25/2016
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 evaluation revealed that the returned device's critical mating features on surface a (surface that mates with the bearing) are within specification.The damages observed on the surfaces were most likely caused during the extraction of the implant.The information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-503-tttc and lot number,108761313 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2014, patient underwent a left tka procedure.On (b)(6) 2016 the surgeon performed a revision left tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-tttc (lot 108761313) (b)(4)) and bearing implant ar-503-bc10 (lot 113601218)(b)(4)).During the revision procedure the surgeon implanted the following arthrex parts: tibial tray ar-513-t2 (lot 10024438), bearing implant ar-513-bc20 (lot 113601352) and stem extension implant ar-523-10100 (lot 10018099).Patient was a female, age (b)(6), dob (b)(6)1962.Patient medical records dated (b)(6) 2016 noted pain was reported at (b)(6) with no new injury.Patient having anterior left knee pain increased in tibial plateau region with weight bearing.Records indicate patient reported walking was painful with some instability in left knee.During examination palpation of the left knee demonstrated medial tibial and lateral tibial plateau tenderness.Patient was tender on the left at: anterior knee pain.Mild effusion of the left knee was noted.X-ray findings revealed left knee prosthesis in proper anatomical alignment without rotation, loosening or stress shielding.

• Brand Name: IBALANCE TKA TIBIAL TRAY, SIZE 2
• Common Device Name: PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5893555
• Report Number: 1220246-2016-00341
• Device Sequence Number: 638657
• Product Code: JWH
• UDI-Device Identifier: 00888867106703
• UDI-Public: 00888867106703
• 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: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2016

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: 09/01/2018
• Device Catalogue Number: AR-503-TTTC
• Device Lot Number: 108761313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Initial Report FDA Received Date: 08/22/2016
• 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: 53 YR