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

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.

• Brand Name: UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E
• Type of Device: PROSTHESIS, 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 Key: 8028713
• MDR Text Key: 125910659
• Report Number: 1220246-2018-00720
• Device Sequence Number: 0
• Product Code: HSX
• Reporter Country Code: US
• PMA/PMN Number: K161060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: UKA TIBIAL BEARING, SIZE 3, 11MM, VIT-E
• Device Catalogue Number: AR-521-TBC1
• Device Lot Number: 5791626
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/01/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other