MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTG
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Swelling (2356)
Date of Event	01/25/2017
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 information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-503-tttg and lot number 108761204 combination found no related information.Device reported discarded by facility.
Event or Problem Description
It was reported that on (b)(6) 2013 a patient underwent a bilateral tka procedure.On (b)(6) 2017 the surgeon performed a revision left tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-tttg, lot 108761204 ((b)(4)), and bearing implant, ar-503-bg08, lot 654433 ((b)(4)).To complete the procedure the surgeon implanted the following arthrex devices: tibial tray, ar-513-t7, lot 10024600, bearing implant, ar-513-bh18, lot 113601405 and stem extension implant, ar-513-1450, lot 10024600.Patient was a male, (b)(6).Additional information from patient medical records: on (b)(6) 2014: assessment - ankylosis of left knee, effusion of lower leg joint.Patient has some play in knee but not enough for surgery at time of notation.On (b)(6) 2015: patient has laxity in left knee.Examination of the left knee demonstrated swelling.Palpation of the left knee demonstrated inferior pole patella tenderness, medial and lateral joint line tenderness and pain with flexion.On (b)(6) 2016: x-ray findings left knee, prosthesis in place in proper anatomical alignment without rotation, loosening, or stress shielding.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 6
• 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: 6386975
• Report Number: 1220246-2017-00049
• Device Sequence Number: 10946759
• Product Code: JWH
• UDI-Device Identifier: 00888867106741
• UDI-Public: 00888867106741
• 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: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: 09/01/2017
• Device Catalogue Number: AR-503-TTTG
• Device Lot Number: 108761204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-503-BG08 IBALANCE TKA BEARING, LOT 654433
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR