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U.S. Department of Health and Human Services

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

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ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number AR-503-TTTE
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.

 
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Brand NameIBALANCE TKA TIBIAL TRAY SIZE 4
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 Key6476676
Report Number1220246-2017-00108
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 04/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/01/2019
Device Catalogue NumberAR-503-TTTE
Device LOT Number1297366
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2017
Was Device Evaluated By Manufacturer? Yes
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: 04/10/2017 Patient Sequence Number: 1
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