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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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ARTHREX, INC. UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E
Device Problems Difficult to Insert (1316); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2018
Event Type  Injury  
Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.

 
Event Description

It was reported that during a right uka procedure, the surgeon had reached the implant insertion step of the technique. He attempted to insert a size 3, 11mm vitamin e tibial poly bearing, ar-521-tbc1; however was meeting resistance during insertion. After pulling the poly bearing out of the joint, the poly was noticed to be deformed. A second size 3, 11mm vitamin e tibial poly bearing, ar-521-tbc1, was opened and the surgeon met the same issue when trying to insert the poly bearing. Again, the poly bearing was found to be deformed. The surgeon took bone away and tried to expose the joint as much as possible with no luck in getting the poly bearing to seat. A third poly bearing was opened and this time, the surgeon tried a size 3, 11mm tibial poly bearing, ar-501-tbc1. As he was attempting to insert this poly bearing, the same issue was present, the poly could not be seated and was found to be deformed after being removed. After a 15 minute delay in case, the surgeon was finally able to implant and seat a fourth size 3, 11mm tibial poly bearing, ar-501-tbc1, with no adverse effect to the patient.

 
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Brand NameUKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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 Key8028713
MDR Text Key125910659
Report Number1220246-2018-00720
Device Sequence Number0
Product Code HSX
Combination Product (Y/N)
Reporter Country CodeUS
PMA/PMN NumberK161060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2018
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E
Device Catalogue NumberAR-521-TBC1
Device LOT Number5791626
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated By Manufacturer? No
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: 11/01/2018 Patient Sequence Number: 1
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