Profemur Hip Implant: Manufacturer, Problems, FDA Recalls, and MDL Lawsuits
Manufacturer and Device Information
The Profemur Hip implant is manufactured by MicroPort Orthopedics, Inc. (formerly Wright Medical) in the US and has been associated with significant complications including modular neck fractures, loosening, and metallosis, with certain models having higher failure rates requiring revision surgeries.
The Profemur system includes several variants, with the most commonly discussed being the Profemur Z and Profemur E models. These are bimodular femoral stems designed with modularity at both the head-neck and neck-body junctions 1.
Major Problems and Complications
Design Issues and Failure Rates
Modular Neck Fractures: The bimodular design has been associated with neck fractures, particularly in:
Aseptic Loosening: The Profemur E model showed particularly high rates of loosening (9%) 1
Other Complications:
Survivorship Concerns
- Studies have reported 85% survivorship for both Profemur E and Z stems at mean follow-up of 50 months 1
- A Slovenian multicenter study found a 97% 12-year survival rate free from aseptic loosening, but still identified concerning rates of neck fractures (0.83%) 2
FDA Recall Information
The evidence provided does not specifically mention an FDA recall of the Profemur hip implant. However, the literature indicates significant concerns with the device:
- Multiple studies report high failure rates of the bimodular neck design 1, 2
- One study explicitly states: "Based on our experience we cannot recommend the use of bimodular femoral neck implants" 1
MDL Lawsuits
The evidence provided does not specifically mention Multidistrict Litigation (MDL) lawsuits related to the Profemur hip implant. However, the documented high failure rates, complications, and specific design issues would typically be grounds for legal action.
Clinical Implications and Management
For Patients with Existing Implants
- Regular radiographic follow-up is recommended for patients with MoM (metal-on-metal) hip implants every 1-2 years 3
- Radiographs should assess component position, loosening, bone quality, osteolysis, fracture, dislocation, femoral neck narrowing, and medial femoral calcar erosion 3
- Ultrasound and MARS-MRI may be beneficial for detecting pseudotumors and other adverse reactions to metal debris in asymptomatic patients 3
For Surgeons and Healthcare Providers
- The presence of hip prostheses makes the site unsuitable for diagnostic bone mineral density assessment; the contralateral side should be used instead 3
- Patients with bimodular Profemur implants, especially young males with long necks and larger head sizes, should be monitored more closely for potential complications 1, 2
Pitfalls to Avoid
- Ignoring subtle radiographic changes: Serial radiographs are essential to detect early signs of failure 3
- Overlooking asymptomatic patients: Complications can develop even in patients without symptoms 3
- Failure to recognize risk factors: Patients with specific risk factors (male sex, higher BMI, long neck components) should be monitored more closely 2
- Inadequate imaging: Standard radiographs may miss soft tissue complications; advanced imaging with ultrasound or MARS-MRI may be necessary 3
The evidence strongly suggests that the risks of using bimodular femoral neck implants like certain Profemur models outweigh the benefits for most patients, with several studies documenting complications that would not have occurred with different stem designs 1, 2.