MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY, SIZE 8; PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/

Catalog Number	AR-503-TTTJ
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Palpitations (2467)
Date of Event	09/12/2016
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 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-tttj and lot number,108761234 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2013 a patient underwent a right tka procedure.On (b)(6) 2016 the surgeon performed a revision right tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar- 503-tttj lot 108761234 ((b)(4)), femoral implant ar-503-psrj lot 108761219 ((b)(4)), bearing implant ar-503-bj15 lot 113601221 ((b)(4)) and patella implant ar-504-psd0 lot 654468 ((b)(4)).To complete the procedure the surgeon used another manufacturer's product.Patient was a male, (b)(6).Patient medical records dated (b)(6) 2016 noted the following: patient continued to have chronic right knee pain and swelling.Examination of the right knee demonstrated warmth and swelling.Palpation of the right knee demonstrated medial joint line tenderness but no lateral joint line tenderness.Moderate effusion of the right knee was also noted.Report summary noted the x-rays showed periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY, SIZE 8
• 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: 6015406
• Report Number: 1220246-2016-00409
• Device Sequence Number: 83458
• Product Code: JWH
• UDI-Device Identifier: 00888867106765
• UDI-Public: 00888867106765
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2016

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: 11/01/2017
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 108761234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 10/10/2016
• 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-BJ15, IBALANCE TKA BEARING, LOT 113601221; AR-503-PSRJ, IBALANCE FEMORAL, LOT 108761219; AR-504-PSD0, IBALANCE PATELLA, LOT 654468
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR