LFIT Anatomic CoCr V40 Femoral Heads
Hazard alert - potential for components to separate
Metal-on-metal hip replacement implants
Information from TGA Australia for general practitioners, orthopaedic surgeons and other health professionals
Biolox Forte 36 mm Alumina ceramic heads - used in hip replacements
Hazard alert from TGA Australia - increased risk of requiring revision.
Consumers and health professionals are advised that a recently published Australian study suggests a higher incidence of first hospitalisation due to heart failure among a group of male patients with ASR XL metal-on-metal (MoM) hip implants when compared with a similar group who had received a metal-on-polyethylene (MoP) implant.
TGA Australia Hazard alert – risk of adverse events due to potential taper lock failures
Consumers and health professionals are advised that Stryker Orthopaedics, in consultation with the TGA, has issued a hazard alert for a specific range of LFIT Anatomic CoCr V40 femoral heads.
The new hazard alert contains updated revision rate data for the resurfacing system.
The new hazard alert contains updated revision rate data for the modular heads.
From TGA Australia "Profemur cobalt-chrome femoral neck - used in hip replacements" Hazard alert
Hazard alert - potential for component failure due to metal fracture.
From TGA Australia, Reclassification of hip, knee and shoulder joint replacements
Total and partial hip, knee or shoulder joint replacements were reclassified as Class III medical devices. This means: increasing the premarket assessment of their safety, quality and performance; and enhancing their identification and traceability by including them in the Australian Register of Therapeutic Goods (ARTG) individually rather than grouping them together under a single ARTG entry.
Consumers and health professionals are advised that Smith & Nephew, in consultation with the TGA, has issued a hazard alert regarding its Birmingham Hip Modular Head (BHMH).
TGA Australia "Defining joint replacement medical devices and ancillary medical devices"
This is guidance for manufacturers and sponsors on regulatory amendments defining shoulder, hip and knee joint replacement medical devices and ancillary medical devices. These are used to to clarify the appropriate classification for various medical devices supplied and used in shoulder, hip and knee joint replacements. The guidance includes examples of how the definition applies to particular devices to illustrate the operation of these definitions.