MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTE
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/13/2017
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.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 catalog number, ar-503-ttte and lot number 1297366, 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.
Event or Problem Description
It was reported that on (b)(6) 2015 patient underwent bilateral tka procedure.Patient had a revision left tka on (b)(6) 2017 due to tibial loosening and pain.During the revision procedure the surgeon explanted the tibial tray ar-503-ttte (lot 1297366), and bearing implant ar-513-be09 (lot 113601338a).To complete the procedure the surgeon implanted the following arthrex products: tibial tray, ar-513-t4 (lot 10060962) and bearing implant, ar-513-be16 (lot 113601340).The following additional information was obtained from patient medical records: records dated (b)(6) 2016: patient bikes, kayaks and does water aerobics and thinks she may have overdone it.X-ray findings left knee: prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.Records dated (b)(6) 2017: patient has been having increased left knee pain.Aspiration fluid two months prior was negative for infection.Patient reported it felt like a tight band across her knee with throbbing and burning pain in the anterior tibia.Examination of the left knee demonstrated no swelling or ecchymosis.Palpation of the left knee demonstrated medical joint line and medial tibial plateau tenderness, but no lateral joint line tenderness and no pes anserine bursa tenderness.Mild effusion of the left knee was noted.X-rays show periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 4
• 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: 6476676
• Report Number: 1220246-2017-00108
• Device Sequence Number: 849838
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 06/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1297366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/10/2017
• 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