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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 8 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 8 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number AR-503-TTTJ
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.

 
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Brand NameIBALANCE TKA TIBIAL TRAY SIZE 8
Type of DevicePROSTHESIS, 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 Key6360421
Report Number1220246-2017-00027
Device Sequence Number1
Product CodeJWH
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 Received02/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/01/2019
Device Catalogue NumberAR-503-TTTJ
Device LOT Number1251021
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 Received01/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1220246-1/29/16-001-R

Patient TREATMENT DATA
Date Received: 02/27/2017 Patient Sequence Number: 1
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