Risk of Periprosthetic Femoral Fractures in Zimmer Biomet CPT Hip System

In July 2024, Zimmer Biomet was issued an urgent medical device Field Safety Notice regarding their CPT Hip System Femoral Stem 12/14 Neck Taper. This device is widely used in hip replacement surgeries for over 20 years and is praised for its high survivorship rates. However, recent data suggests an increased risk of periprosthetic femoral fractures (PFF) associated with this product. This post aims to explain what this recall means for hospitals, surgeons, and patients.

What is the CPT Hip System?

The CPT Hip System Femoral Stem 12/14 Neck Taper is a taper-slip (PTS) stem for hip replacement surgeries. This device, made from cobalt chromium alloy, has been a popular choice due to its durability and low rates of aseptic loosening, a common issue with other hip implants. Over the years, the CPT Hip System has gained a reputation for long-term success. There is a 96.4% survivorship rate at 10 years, according to the United Kingdom National Joint Registry (UK NJR).

Why the Recall?

The safety notice highlights that while PTS stems generally have good performance, they come with an elevated risk of PFF compared to other types of femoral stems. The CPT Hip System Femoral Stem 12/14 Neck Taper, in particular, has shown a PFF rate of 1.4%. This is more than double the risk of a comparable stainless steel product. 

PFFs are fractures that occur near the femoral implant, usually following trauma, such as a fall. These fractures can be severe and often require additional surgeries, including possible replacement of the femoral stem. Unfortunately, the Instructions for Use (IFU) provided by Zimmer Biomet do not currently mention this risk, leading to the issuance of the Field Safety Corrective Action.

Who is at Risk?

Hospitals and surgeons who have implanted the CPT Hip System Femoral Stem in the past 12 months are receiving this notice. Facilities that currently have this product in their inventory are also at risk. Zimmer Biomet is working to phase out the CPT Hip System by the end of 2024 and is offering training to help medical professionals transition to other available hip systems.

Risks to Patients

The main risk highlighted in the safety notice is the increased chance of PFF following surgery. Key factors that may contribute to the risk of PFF include:

– Increasing age

– Intra-operative fracture

– Use of larger femoral heads

– Low viscosity bone cement

For patients, this means an increased chance of requiring additional surgeries should a fracture occur. Zimmer Biomet has committed to updating their IFU by August 2024 to ensure future patients and surgeons are fully informed of these risks.

Surgeon and Hospital Responsibilities

Surgeons need to weigh the benefits and risks of using the CPT Hip System Femoral Stem on a case-by-case basis. This is due to the increased risk of PFF. Hospitals require acknowledgement of a receipt of the Field Safety Notice and ensure to inform all contents to relevant.

Key steps outlined for healthcare providers include:

– Reviewing the safety notice and informing all personnel

– Coordinating with Zimmer Biomet on a transition plan for the product

– Completing a Certificate of Acknowledgment to confirm receipt of the notice

– Advising patients of the risks and discussing potential alternative hip systems

What Happens Next?

Zimmer Biomet plans to stop sales of the CPT Hip System by December 2024 and phase it out from all markets. Until then, the product may continue to be used, but surgeons and hospitals are advised to communicate the risks of PFF to patients and adjust their surgical planning accordingly.

Patient and Surgeon Dialogue

As with any medical device, it is essential for patients to fully understand the risks associated with their hip replacement. Surgeons play a critical role in educating their patients about potential complications like PFF, ensuring that they make informed decisions about their health. Zimmer Biomet’s efforts to phase out the product and provide alternative options show a commitment to patient safety, but it remains crucial for healthcare providers to stay vigilant.

If you or a loved one is affected by the use of the CPT Hip System Femoral Stem, discuss the potential risks with your healthcare provider. This will help ensure that the best decisions are made for your specific situation, minimizing the risks of complications post-surgery.

For any further questions or concerns, contact Zimmer Biomet directly or consult your medical team.

KBA’s Involvement with Zimmer Biomet

KBA Attorneys is investigating Zimmer Biomet, and the increased risk of Periprosthetic Femoral Fractures in patients. Contact us if you have been injured by this product. We are currently litigating cases involving other hip implant fractures and failures.