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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA BEARING, PS SIZE 7, 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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ARTHREX, INC. IBALANCE TKA BEARING, PS SIZE 7, 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number IBALANCE TKA BEARING, PS SIZE 7, 10MM
Event Date 06/08/2018
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 dhr review for this catalog number, ar-503-bh10 and lot number, 113601221 combination found no related information.

 
Event Description

It was initially reported by patient through the arthrex website, that the patient had total knee replacement procedure on both knees using arthrex products. (reference cc138269) patient provided the following information 2/13/2018: initial surgery was (b)(6) 2013. Two years after surgery patient started to have swelling and pain in his knee. Surgeon had drained patient's knee three different times (around every 6 months), which brought him no relief. Surgeon informed patient that the compound (cement) used to adhere the implant was coming loose and he was most likely going to require a replacement. Patient stated his left knee is getting worse and his knee "slips out of place". Patient reported instability and pain in both knees that is so bad that sometimes he falls. Patient said his right knee is starting to have the same problems. When patient walks both knees shift. Patient stated he has pictures that show a "separation" of the implant. Arthrex requested that if a revision is performed, would he be willing to release the product to arthrex so that the implants could be inspected and so arthrex could report the findings back to patient. The following arthrex devices were implanted during the (b)(6) 2013 bi-lateral tka procedure: ar-503-ttth, lot 108761229, qty1. Ar-503-ttth, lot 108761238, qty 1. Ar-503-bh10, lot 113601221, qty 2. Ar-503-pslj, lot 108761215, qty 1. Ar-503-psrj, lot 108761219, qty 1. Ar-504-psd0, lot 654468, qty 2. On 6/5/2018 notice was received from patient that he is scheduled for left total knee revision surgery on (b)(6) 2018. Patient states revision is being performed due to left knee becoming loose and unstable. Original implant surgeon is scheduled to perform the revision procedure. Patient is requesting that his explanted devices be returned to arthrex for evaluation. Patient also stated that in the near future his right knee will need to be replaced for the same reasons. Additional information obtained 6/26/2018: arthrex has received confirmation that the planned revision procedure took place as scheduled on (b)(6) 2018. The following are the implants that were explanted on (b)(6) 2018: ar-503-ttth, lot 108761229, qty 1. Ar-503-bh10, lot 113601221, qty 1. Ar-503-pslj, lot 108761215, qty 1. Ar-504-psd0, lot 654468, qty 1.

 
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Brand NameIBALANCE TKA BEARING, PS SIZE 7, 10MM
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
8009337001
MDR Report Key7703843
Report Number1220246-2018-00557
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date08/31/2017
Device MODEL NumberIBALANCE TKA BEARING, PS SIZE 7, 10MM
Device Catalogue NumberAR-503-BH10
Device LOT Number113601221
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/19/2018 Patient Sequence Number: 1
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