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

Device Problems Failure To Adhere Or Bond (1031); Nonstandard Device (1420)

Patient Problem Pain (1994)

Event Date 03/13/2017

Event Type  Injury  

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 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
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6476676
• Report Number: 1220246-2017-00108
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888867106710
• UDI-Public: 00888867106710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1220246-1/29/16-001-R
• Patient Outcome(s): Other