MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 7
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Swelling (2091); Fluid Discharge (2686)
Date of Event	09/17/2018
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-ttth and lot number 1380710 , 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.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It has been reported that on (b)(6) 2015 a patient underwent a total knee procedure.The tibial tray implanted during this procedure was ar-503ttth, lot 1380710.Patient developed a serious infection in his knee which required having to have fluid drawn from his knee, the parts then had to be explanted in a second surgery where a temporary spacer was put in place, he then underwent a lengthy series of iv antibiotics and eventually had another surgery to redo the knee with new implants.Patient is currently doing well.Patient did not have all of his records available at the time of call so additional information has been requested.Additional information obtained 9/21/18: patient underwent a right tka procedure on (b)(6) 2015 during which the following devices were implanted: tibial tray implant, ar-503-ttth, lot 1380710; femoral implant, ar-516-7r, lot 1355182; tibial bearing implant, ar-513-bh12, lot 113601341; and patella implant, ar-504-psd0, lot 113601439.Almost immediately after having the procedure the patient began to have infection symptoms which included: swelling, redness and the incision was leaking fluid including blood.On (b)(6) 2015 the patient's knee was drained to provide some relief; however the symptoms did not dissipate and continued.On (b)(6) 2016 the patient underwent surgery with a different surgeon at a different facility.During the procedure the four original tka implants were explanted and a temporary spacer was inserted.New implants could not be inserted until the infection was allowed to clear over 6 weeks and the patient underwent iv antibiotic treatment.On (b)(6) 2016 the second surgeon then went back in (at the same facility as the second surgery) and was able to insert another manufacturer's tka implants.At time of report patient is doing well.Patient is unaware if the devices were kept by the facility or not.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 7
• 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: 7943071
• Report Number: 1220246-2018-00692
• Device Sequence Number: 14037941
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 05/31/2019
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 7
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 1380710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/08/2018
• 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
• Outcome Attributed to Adverse Event: Other