| 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 |
|
| 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 |