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

Device Problems Nonstandard Device (1420); Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 01/30/2017

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. This is one of four submissions from the same patient event. The others are 1220246-2017-00028 ((b)(6)), 1220246-2017-00029 ((b)(6)), and 1220246-2017-00030 ((b)(6)). The device was not returned for evaluation and the contribution of the device to the reported event could not be determined. The catalog number, ar-503-tttj and lot number 125021, 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 a patient underwent a left tka procedure. On (b)(6) 2017, the surgeon performed a revision left tka due to unexplained pain and loose tibia. During the revision procedure the surgeon explanted the (tibial tray ar-503-tttj, lot 1251021, ((b)(6)), bearing implant ar-513-bj13, lot 113601404 ((b)(6)), femoral implant ar-516-8l, lot 108761335 ((b)(6)) and patella implant ar-504-psc9, lot 113601437 ((b)(6)). To complete the procedure the surgeon used another manufacturer's product. Patient was a male, dob (b)(6) 1956. Patient was in the obese range by bmi at the time of initial which is contraindicated for tka. Patient medical records dated (b)(6) 2016 noted: left knee x-ray findings - prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding. Records noted patient would start weight loss program to see if it would make any difference. Patient medical records date (b)(6) 2016 noted: patient had a i&d of hematoma on (b)(6) 2015. Patient has had embolizations x3, patient was noted to have decreased mobility, pain with sleeping, walking, stairs and all weight bearing activities. Examination of the left knee demonstrated swelling and well healing incision, venous insufficiency leg edema. Palpation of the left knee demonstrated inferior pole patella tenderness as well as both medial and lateral tibial plateau tenderness. Mild effusion of the left knee was noted. Records noted x-rays showed no change since (b)(6) 2016.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 8
• 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: 6360421
• Report Number: 1220246-2017-00027
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/01/2019
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 1251021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 60 YR
• Patient Weight: 181
• Patient Outcome(s): Other