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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01649-1
Product Name/Description SMF and MDF Modular Neck Hip Prosthesis

Multiple products affected

Previous ARTG Number: 101100
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/12/2016
Responsible Entity Smith & Nephew Pty Ltd
Reason/Issue During a recent review of product complaints received by Smith & Nephew and clinical study data associated with the modular hip prostheses, a rate of complaints higher than comparable monolithic hip prostheses was observed.

Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for Modular SMF and 0.25% for Modular REDAPT Revision Femoral Hip Systems. Overall, the metal-related Adverse Events accounted for the highest category of complaints in both products.
Recall Action Hazard Alert
Recall Action Instructions Smith & Nephew is advising physicians to maintain their routine follow-up protocol for patients who have undergone total hip arthroplasty and continue to monitor for pain, swelling, limited mobility and enlarged bursa. For symptomatic patients, physicians may consider additional clinical follow-up. The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients’ clinical circumstances. Follow-up examinations should be repeated for symptomatic patients annually for the lifetime of the device to potentially help reduce the risk of complication and the need for additional surgery.
Contact Information 02 9857 3908 - Smith & Nephew