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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00436-1
Product Name/Description	Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular Cup CHR Dysplasia Cup BIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper Sleeve BIRMINGHAM HIP Modular Head Monoblock 38MM~58MM Multiple Catalogue Numbers affected All batches affected ARTG Numbers:120078, 124099, 124100
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/05/2016
Responsible Entity	Smith & Nephew Pty Ltd
Reason/Issue	Smith & Nephew is issuing an update to a Medical Device Hazard Alert issued in 2015 to provide surgeons and hospitals with updated information on the BIRMINGHAM HIP RESURFACING (‘BHR’) product range and the BIRMINGHAM HIP MODULAR HEAD (BHMH) System. This update contains a current summary of the information concerning the revision rates of various products in the BHR and BHMH Systems (including the Monoblock version of the BHMH System).
Recall Action	Hazard Alert
Recall Action Instructions	The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. This action has been closed-out on 24/05/2017.
Contact Information	02 9857 3908 - Smith & Nephew