FAQ
Zimmer Biomet CPT Hip System Fracture Lawsuit
On July 2, 2024, medical device maker Zimmer Biomet initiated a voluntary recall of instructions for the Zimmer Biomet CPT Hip System due to an increased risk of thigh bone fracture risk. Though the company has also stated plans to discontinue the device by December 2024, it may continue to be implanted until then.
Recent research has also revealed that patients with the CPT Hip System face more than double the risk of thigh bone fractures compared to similar hip replacement devices, leading to serious safety concerns from regulators.
Based on these concerns, in September 2024, the U.S. Food and Drug Administration (FDA) issued a safety communication warning of the increased risk of thigh bone fractures in patients who received the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System).
Patients who received a Zimmer Biomet CPT Hip System implant may be eligible for compensation.
Zimmer Biomet CPT Hip System Components Recall
A recall of the instructions for Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper was issued by the manufacturer on July 2, 2024. This recall announcement was followed in September 2024, by a safety alert issued by the FDA and a statement from manufacturer announcing intentions to discontinue the device by December.
Devices impacted by the CPT Hip recall may include:
Item Number | Device Identifier | Item Description |
00-8114-000-00 | 00889024145733 | Size 0 105 mm Stem Length Standard Offset |
00-8114-000-10 | 00889024145740 | Size 0 105 mm Stem Length Extended Offset |
00-8114-001-00 | 00889024145757 | Size 1 130 mm Stem Length Standard Offset |
00-8114-001-10 | 00889024145764 | Size 1 130 mm Stem Length Extended Offset |
00-8114-002-00 | 00889024145771 | Size 2 130 mm Stem Length Standard Offset |
00-8114-002-10 | 00889024145788 | Size 2 130 mm Stem Length Extended Offset |
00-8114-002-30 | 00889024145801 | Size 2 130 mm Stem Length Extra Extended Offset |
00-8114-003-00 | 00889024145818 | Size 3 130 mm Stem Length Standard Offset |
00-8114-003-10 | 00889024145825 | Size 3 130 mm Stem Length Extended Offset |
00-8114-003-30 | 00889024145849 | Size 3 130 mm Stem Length Extra Extended Offset |
00-8114-004-00 | 00889024145856 | Size 4 130 mm Stem Length Standard Offset |
00-8114-004-10 | 00889024145863 | Size 4 130 mm Stem Length Extended Offset |
00-8114-004-30 | 00889024145900 | Size 4 130 mm Stem Length Extra Extended Offset |
00-8114-005-00 | 00889024145917 | Size 5 130 mm Stem Length Standard Offset |
00-8114-005-10 | 00889024145924 | Size 5 130 mm Stem Length Extended Offset |
00-8114-005-30 | 00889024145931 | Size 5 130 mm Stem Length Extra Extended Offset |
00-8114-040-00 | 00889024145962 | Extra Small 85 mm Stem Length |
00-8114-050-00 | 00889024145979 | Small 95 mm Stem Length |
00-8114-002-18 | 00889024145795 | Size 2 180 mm Stem Length Standard Offset |
00-8114-003-18 | 00889024145832 | Size 3 180 mm Stem Length Extended Offset |
00-8114-004-20 | 00889024145870 | Size 4 200 mm Stem Length Extended Offset |
00-8114-004-23 | 00889024145887 | Size 4 230 mm Stem Length Extended Offset |
00-8114-004-26 | 00889024145894 | Size 4 260 mm Stem Length Extended Offset |
00-8114-012-18 | 00889024145948 | Size 2 180 mm Stem Length Valgus Neck |
00-8114-013-18 | 00889024145955 | Size 3 180 mm Stem Length Valgus Neck |
Serious Complications from CPT Hip System
The Zimmer Biomet CPT Hip Femoral Stem is part of the Zimmer Biomet family of hip joint replacement devices. It is a polished-taper slip (PTS) style stem made from cobalt chromium alloy. Though the manufacturer has stated intention to discontinue providing the component, the FDA has expressed concerns about this device continuing to be implanted in new patients due to:
- Increased risk of post-surgical thigh bone fracture compared to similar devices
- Possible need for additional surgical intervention if fracture occurs
- Manufacturer’s planned phase-out of the device
Complications of Zimmer Biomet CPT Hip System
Failure of the Zimmer Biomet CPT Femoral Stem component after implantation as part of a hip replacement surgery may result serious complications due to thigh bone fracture.
Other complications may include:
- Unexpected thigh pain
- Difficulty walking
- Need for revision surgery
- Extended recovery time
- Additional medical expenses
FDA Safety Alert and Recall
On September 17, 2024, the FDA issued a safety communication alerting patients, caregivers, and healthcare providers about the increased risk of postoperative periprosthetic femoral fracture with the CPT Hip System. Following this, on September 18, 2024, Zimmer Biomet sent a follow-up letter to U.S. surgeons and announced plans to exit the U.S. market.
FDA Recommendations for Zimmer Biomet CPT Hip System
The FDA does not recommend removal of a well-functioning CPT Hip System. Patients and caregivers were advised to continue with existing care and to consult with their healthcare providers if unexpected symptoms like pain or difficulty walking occur.
Surgeons, Healthcare providers and Surgical facilities have been advised to consider alternative implant devices when possible and to reserve use of the CPT Hip System devices only when the benefits outweigh the possible risks of the devices. In addition, patients should be informed of the risks and report any symptoms of failure to their provider.
If you or a loved one received a Zimmer Biomet CPT Hip System implant or experienced complications including thigh bone fracture, you may be eligible for compensation.