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

Model Number IBALANCE TKA TIBIAL TRAY SIZE 4

Device Problems Loose or Intermittent Connection (1371); Microbial Contamination of Device (2303); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060)

Event Date 04/29/2019

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 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 device history record review for this catalog number, ar-503-ttte and lot number 108761149 combination found no related information.

Event Description

It was reported that the patient underwent a left tka procedure on (b)(6) 2013.During this procedure the following devices were implanted: ar-503-ttte (lot 108761149), ar-503-psle, femoral implant (lot 108761204), ar-503-be09, bearing implant (lot 654422), ar-504-psb8, patella implant (lot 654465).Almost immediately after the surgery the patient began experiencing pain and a clicking/crunching sound in her knee.The patient reported she followed all post-surgery orders and performed all the physical therapy as ordered.During the course of the first year after the tka procedure, the surgeon had to drain fluid from the patient¿s knee three or four times.The patient continued to experience pain and the clicking/crunching sound.On (b)(6) 2014, the original tka surgeon performed a procedure to clean out the scar tissue from the patient¿s joint.The patient¿s issues still persisted.Since the scar tissue removal procedure, the patient had a bone scan that indicated the knee joint had an infection in the joint/bone/tissue or an implant was loose.According to the patient the original tka surgeon was not alarmed or concerned by the bone scan findings and informed her that the knee was fine and the pain and sounds/feelings she was experiencing were normal.The patient continued living with the pain and clicking/crunching sound in her knee and had to take aleve daily to try and tolerate the issues.In 2019, the patient was seen by a different surgeon for a second option, this surgeon advised her that the bone scan findings and tests indicated that she needed a tka revision.Thereafter, on (b)(6) 2019 a left revision tka procedure was performed by the second option surgeon.At the time of revision all original arthrex tka components were explanted and another manufacturer's product was used to complete the revision procedure.Since revision, the patient has been rehabbing and is no longer experiencing the issues previously reported.The patient states that the facility has confirmed the explanted devices are being held and she will request that the facility return the devices to arthrex.Additional information obtained 10/31/19: the following devices were implanted during the (b)(6) 2013 procedure and explanted during the (b)(6) 2019 procedure: ar-503-ttte, tibial tray implant (lot 108761149), ar-503-psle, femoral implant (lot 108761204), ar-503-be09, bearing implant (lot 654422), ar-504-psb8, patella implant (lot 654465).

Manufacturer Narrative

The evaluation revealed the returned device's critical mating feature (top surface a that mates with the poly bearing) are within specifications.The damages observed on the surfaces a and b, as well as the sides of the device were most likely caused during the extraction of the implant.

• 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
• MDR Report Key: 9369093
• MDR Text Key: 168012324
• Report Number: 1220246-2019-01433
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• Combination Product (y/n): N
• PMA/PMN Number: K081127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: IBALANCE TKA TIBIAL TRAY SIZE 4
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 108761149
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 03/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other