MicroPort Recalls PROFEMUR Titanium Hip Prosthesis Components Due to Fracture Reports
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device (fracture of the femoral neck component) which poses a significant risk of injury to patients, meeting the criteria for a Severe rating.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 556 units of the PROFEMUR Neck Extra Long Titanium hip prosthesis component, specifically catalog numbers PHA01206, PHA01236, and PHA01256. The recall covers all lots and serial numbers for these specific catalog numbers.
The recall is being issued because of reports of fractures in the long and extra-long Titanium modular femoral neck component after it has been implanted in patients. According to the company, there were 680 fractures of these components worldwide among 123,840 global sales from 2002 to 2019, representing a cumulative fracture rate of 0.55%. In the United States, there were 349 fractures among 15,786 sales during the same period, a rate of 2.21%. The average time to device fracture after implantation is 5.4 years.
The affected products were distributed worldwide, except for China and Japan. Patients who have had these specific components implanted should contact their healthcare provider to discuss the recall and potential risks.
The recalled product
- Product
- PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 556
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots/serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by MicroPort Orthopedics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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