MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB CEMENTED TRAY, SIZE 5 RM/LL; KNEE PROSTHESIS

Model Number IBAL UKA TIB CEMENTED TRAY, SIZE 5 RM/LL

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

On 03/13/2024, it was reported by a sales representative via e-mail that ((2) ar-521-tbe8 ibalance® uka tibial bearing implants were not locking into the ar-511-t5r ibalance® uka tibial tray.This occurred during a case.No additional information was provided, and additional information has been asked.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: IBAL UKA TIB CEMENTED TRAY, SIZE 5 RM/LL
• Type of Device: KNEE PROSTHESIS
• 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: jared engle ; 8009337001
• MDR Report Key: 19002828
• MDR Text Key: 338927556
• Report Number: 1220246-2024-01728
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00888867334243
• UDI-Public: 00888867334243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBAL UKA TIB CEMENTED TRAY, SIZE 5 RM/LL
• Device Catalogue Number: AR-511-T5R
• Device Lot Number: 15047232
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• 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