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

Catalog Number	AR-503-TTTJ
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Swelling (2356)
Date of Event	02/13/2017
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.No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.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.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 contribution of the device to the reported event could not be determined.
Event or Problem Description
It was reported that on (b)(6) 2013 a patient underwent a left tka procedure.On (b)(6) 2017 the surgeon performed a revision left tka due to tibial loosening.During the revision surgery the surgeon explanted the following arthrex parts: tibial tray, ar-503-tttj, lot 108761234, femoral implant, ar-503-pslj, lot 108761211, bearing implant, ar-503-bj18, lot 113601221 and patella implant, ar-504-psd0, lot 113601237.The revision procedure was completed using another manufacturers product.The following has been obtained from patient medical records: records dated (b)(6) 2014: ap and lateral x-rays of left knee identified a well placed total knee prosthesis in good anatomic alignment, without signs of loosening, fracture, infection or other abnormalities.Records dated (b)(6) 2014: large effusion of left knee, range of motion examination of left knee demonstrated minor crepitus with motion.Left knee aspirated and injected.Records dated (b)(6) 2014: palpation of the left knee demonstrated patellofemoral region tenderness, but no medial or lateral joint line tenderness.Mild effusion of left knee.Prior august 2014 aspiration results of fluid testing were negative.Records dated (b)(6) 2015: left knee x-ray findings - prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.Records dated (b)(6) 2016: patient was doing well until working out in gym and knee swelled up.Some lateral compartment pain, buckling sensation of knee on occasion.Some mid flexion laxity on exam and continues with swelling.Surgeon discussed tibial revision but patient felt knee was livable at that time.Records dated (b)(6) 2016: x-rays shoed periarticular osteophytes and joint space narrowing.Pain in knee increased with activity and weight bearing.Interference with activities of daily living.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 8
• 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: 6405441
• Report Number: 1220246-2017-00059
• Device Sequence Number: 13594674
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2017

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-TTTJ
• Device Lot Number: 108761234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other