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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00210-1
Product Name/Description	METAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAT (Acetabular shell component used for hip replacement) Catalogue numbers: 15800144, 15800146, 15800148, 15800150, 15800152, 15800154, 15800156, 15800158, 15800160, 15800162, 15800164, 15800166, 15800168 All batch numbers affected ARTG Number: 191888
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/03/2015
Responsible Entity	RQSolutions Medical Devices Distribution Support
Reason/Issue	The ‘DeltaLox’ acetabular shells have a higher than expected revision rate as reported by the Australian Orthopaedics Association National Joint Replacement Registry. An analysis published alongside the 2014 Annual Report of the AOANJRR indicates that the yearly cumulative percent revision is 5.9% at 1 year and 9.0% at 2 years. In comparison, the cumulative percent revision for other total conventional hip replacements is 1.6% at 1 year and 2.1% at 2 years. The main reasons for revision have been dislocation, loosening/lysis and fracture.
Recall Action	Hazard Alert
Recall Action Instructions	Implanting surgeons are advised to schedule annual clinical and radiological examinations for patients who have been implanted with this device, in accordance with routine patient post-arthroplasty care. RQSolutions Medical Devices Distribution Support Pty Ltd is also undertaking a recall of un-implanted stock. RQSolutions has ceased supply of ‘DeltaLox’ acetabular implants and is cancelling them from the Australian Register of Therapeutic goods (ARTG). For additional information please see https://www.tga.gov.au/alert/deltalox-acetabular-shells-used-hip-implants . This action has been closed-out on 09/08/2016.
Contact Information	02 9982 2030 - RQSolutions