MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTF
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Swelling (2091)
Date of Event	12/09/2016
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 information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-503-tttf and lot number 108761211 combination found no related information.Facility sent device to third party.
Event or Problem Description
It was reported that on (b)(6) 2015 a patient underwent a right tka procedure.On (b)(6) 2017 patient had a right tka revision due to tibial loosening.During the revision surgery the following arthrex products were explanted: tibial tray, ar-503-tttf, lot 108761211 ((b)(4)) and the bearing implant ar-513-bf10, lot 113601414 ((b)(4)).To complete the procedure an arthrex tibial tray size 6 and an arthrex bearing implant 16 mm were implanted.Patient is a female, dob: (b)(6).Patient had a history of morbid obesity with a gastric bypass surgery.Patient was in the obese range by bmi ((b)(6)) at the time of revision which is contraindicated for tka.Surgeon reported that patient fell post operatively.Bone scan results (b)(6) 2016: initial perfusion images were unremarkable.The blood pool and delayed images demonstrated increase activity in the region of the right proximal tibia medially greater than laterally.It was noted that this is likely related to postsurgical change.Results mentioned that infection/loosening is less likely but cannot be excluded.Diagnosis indicated probable post-surgical changes of the right knee.Patient medical records dated (b)(6) 2016 noted: patient reported continued pain and swelling with mild feelings of instability.She also reported having some medial pain around tibial plateau with weight bearing activities, walking, daily household chores.She reported being unable to exercise.Kneeling and squatting are painful but normal standing was okay.Patient was noted to walk with slight limp and has days of swelling.Examination of the right knee demonstrated swelling.Palpation of the right knee demonstrated medial tibial plateau and lateral tibial plateau tenderness.Mild effusion of the right need was also noted.Range of motion exam demonstrated no crepitus with motion.Pain with flexion but no pain with extension were noted.Records also noted she does have play with mid flexion laxity.It was discussed with patient that she may have micro-motion of tibial component, has some mid flexion laxity on exam and patient was told she would have to wait until (b)(6) 2017 for a procedure.Medical records date (b)(6) 2016 noted: records noted that surgeon recommended a total knee due to pain in the knee that is increased with activity and weight bearing.Patient also had interference with activities of daily living.Patient had pain with a limited passive range of motion with crepitus and swelling.Records noted that the patient x-rays showed periarticular osteophytes and joint space narrowing.Operative report dated (b)(6) 2017 noted: "decision was made to remove the polyethylene bearing and possibly increase it 1-2 mm.After removing it pliers were placed on the tibia and with compression and distraction there was no obvious loosening or expression of serous fluid at the cement tibial interface.The surgeon actually lifted the lower leg off the table with the pliers on the tibia and it would not disengage from the cement.The tibial was subluxed forward and osteotome was placed on the anterior lip of the tibia and it was tapped with moderate force.On the third tap the tibial was sprung loose from the cement interface.There was no cement adhered to the tibial component or any bone.The third tap of moderate force separated and debonded the tibia from the cement without evidence of gross loosening.".

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 5
• 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: 6321859
• Report Number: 1220246-2017-00020
• Device Sequence Number: 1251459
• Product Code: JWH
• UDI-Device Identifier: 00888867106710
• UDI-Public: 00888867106710
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

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: 06/01/2018
• Device Catalogue Number: AR-503-TTTF
• Device Lot Number: 108761211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/10/2017
• 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-513-BF10 IBALANCE TKA BEARING, LOT 113601414
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 102