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	Fall (1848); Joint Swelling (2356); Weight Changes (2607)
Date of Event	02/20/2017
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.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-tttj and lot number 108761232 combination found no related information.Facility discarded the device.
Event or Problem Description
It was reported that a patient had a right tka procedure on (b)(6) 2014 during which the patella was not resurfaced.The surgeon performed a revision right tka on (b)(6) 2017 due to tibial loosening.During the revision procedure the surgeon explanted the following arthrex products: tibial tray, ar-503-tttj, lot 108761232, femoral implant, ar-503-psrj, lot 108761216, and bearing implant, ar-503-bj18, lot 113601221.The revision procedure was completed using another manufacturer's product.It has been reported that the surgeon chose not to request patient authorization to return explants for evaluation and the explants were discarded at the time of surgery.Additional information obtained from patient medical records: records dated (b)(6) 2015: records noted patient also has a history of gastric bypass surgery for morbid obesity.Records dated (b)(6) 2015: records noted patient was obese at (b)(6) lbs (which is a contraindication for tka - patient's weight at the time of (b)(6) 2014 surgery is unknown).Records dated (b)(6) 2016: x-ray findings right knee -prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.X-rays show periarticular osteophytes and joint space narrowing.Examination of the right knee demonstrates swelling but no erythema and no ecchymosis.Palpation of the right knee demonstrates medial joint line, medial tibial plateau and lateral tibial plateau tenderness.Patient was tender on the right at diffuse.Mild effusion of the right knee was noted.(b)(6) 2016 records also noted that on (b)(6) 2015 patient was working when a semi truck's gas tank exploded above him.Explosion caused patient to go down on both knee's.Patient blacked out and woke up at hospital.X-rays taken - no fx seen right knee effusion.Records noted patient did not have pain prior to the injury.Also noted, patient's bone scan showed possible loosening after the fall.

• 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: 6401992
• Report Number: 1220246-2017-00072
• Device Sequence Number: 773362
• 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: 2014
• 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): 03/14/2017

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: 12/01/2017
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 108761232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/14/2017
• 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