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

Catalog Number	AR-503-TTTH
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Date of Event	12/19/2016
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-ttth and lot number 108761229 combination found no related information.
Event or Problem Description
It was reported that on (b)(6) 2013 a patient underwent a bi-lateral tka procedure.On (b)(6) 2016 surgeon performed a revision left tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-ttth, lot 108761229 ((b)(4)), femoral implant ar-503-pslj, lot 108761215 ((b)(4)), bearing implant ar-503-bh10, lot 113601229 ((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).Medical records dated (b)(6) 2016: findings left knee x-ray: no acute fracture, no acute dislocation, no loose bodies noted and prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.Medical records dated (b)(6) 2016: records revealed examination of the left knee demonstrated swelling.Palpation of the left knee demonstrates inferior pole patella tenderness as well as medial tibial and lateral tibial plateau tenderness.Moderate effusion of the left knee was noted.Patient had pain with flexion but no pain with extension.Surgeon recommended a total left knee revision due to pain in the knee that is increased with activity and weightbearing.Patient has pain through limited passive range of motion with crepitus and swelling.Records noted the patient x-rays show periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY, SIZE 7
• 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: 6259663
• Report Number: 1220246-2016-00603
• Device Sequence Number: 496909
• Product Code: JWH
• UDI-Device Identifier: 00888867106758
• UDI-Public: 00888867106758
• 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): 01/18/2017

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: 11/01/2017
• Device Catalogue Number: AR-503-TTTH
• Device Lot Number: 108761229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 01/18/2017
• 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-BH10, IBALANCE TKA BEARING, LOT 113601229; AR-503-PSLJ IBALANCE TKA FEMORAL, LOT 10871215; AR-504-PSDO IBALANCE TKA PATELLA, LOT 654468
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR