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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01183-1
Product Name/Description	Birmingham Hip Modular Head (BHMH) - Monoblock version Model Numbers: 74121238, 74121242, 74121246, 74121250, 74121254, 74121258, 74121338, 74121342, 74121346, 74121350, 74121354, 74121358, 74121438, 74121442, 74121446, 74121450, 74121454, 74121458, 74121538, 74121542, 74121546, 74121550, 74121554 and 74121558 All batches affected The device has not been available in Australia since 2012.
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/12/2015
Responsible Entity	Smith & Nephew Surgical Pty Ltd
Reason/Issue	A performance review has been conducted of the monoblock Birmingham Hip Modular head (BHMH). Based on the analysis of this information, Smith & Nephew considers that patients implanted with the monoblock BHMH device may be at greater risk of revision surgery.
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, pseudotumors, 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.
Contact Information	02 9857 3999 - Smith & Nephew