MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTE
Health Effect - Clinical Codes	Pain (1994); Pleural Effusion (2010); Swelling (2091)
Date of Event	08/16/2016
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 catalog number, ar-503-ttte and lot number 1297084, 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.If additional relevant information is received, a follow-up report will be submitted.Per customer, device not being returned.
Event or Problem Description
It was reported that on (b)(6) 2015, 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-ttte, lot 1297084 ((b)(4)), femoral implant ar-516-5r, lot 108761350 ((b)(4)), bearing implant ar-513-be12, lot 113601403 ((b)(4)) and patella implant ar-504-psb8, lot 113601439 ((b)(4)).To complete the procedure, the surgeon used another manufacturer's product.Patient was a female, dob (b)(6).Patient medical records dated (b)(6) 2016 noted that patient has developed pain and swelling of the knee without injury, daily medial pain that gets worse with activity.Examination of the right knee demonstrated swelling and palpation of the knee demonstrated inferior patellar pole tenderness, medial tibial plateau tenderness.Moderate effusion of the right knee was noted, along with pain with flexion and no pain with extension.Records noted x-rays of right knee found the prosthesis in proper anatomical alignment without rotation, loosening, or stress shielding and hardware was noted to be in acceptable position.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 4
• 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: 5940610
• Report Number: 1220246-2016-00372
• Device Sequence Number: 10956061
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/11/2016

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: 06/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1297084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2016
• Initial Report FDA Received Date: 09/09/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AR-504-PSB8, IBALANCE PATELLA IMP. LOT 113601439; AR-513-BE-12, IBALANCE TKA BEARING, LOT 113601403; AR-516-5R, IBALANE, TKA FEMORAL IMP. LOT 108761350
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR