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 (fractures of hip prosthesis components) with reported device failures, which aligns with the rubric criteria for 'Severe' (structural defect or significant injury/property-damage reports).
Plain-English summary
MicroPort Orthopedics Inc. is recalling the PROFEMUR Neck Long Titanium hip prosthesis components, including catalog numbers PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, and PHA01264. The recall covers 123,284 units distributed worldwide, excluding China and Japan.
The recall is being conducted because of reports of fractures in the long and extra-long Titanium modular femoral neck components after they were implanted in patients. The company reports that globally, there were 680 fractures among 123,840 sales from 2002 to 2019, resulting in a cumulative fracture rate of 0.55%. In the United States, there were 349 fractures among 15,786 sales during the same period, representing a cumulative rate of 2.21%. The average time to device fracture after implantation is 5.4 years.
Patients who have had these specific hip prosthesis components implanted should contact their healthcare provider to discuss the recall and potential next steps.
The recalled product
- Product
- PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 123,284
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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