91³Ô¹ÏÍø

Post-Operative Patient Information Regarding the CPT Hip System Femoral Stem 12/14 Neck Taper
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• This information is for patients who received a specific type of total hip replacement that was manufactured by 91³Ô¹ÏÍø.ÌýÌý
  
• More specifically, 91³Ô¹ÏÍø is conducting a voluntary medical device correction related to the CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Femoral Stem) due to an increased risk of postoperative periprosthetic femoral (thigh) bone fracture (PFF).ÌýÌý
• All hip replacements have potential risks associated with their use, including fracture of the femoral bone after surgery.Ìý This is typically caused by a traumatic event, such as a fall.Ìý The CPT Femoral Stem did not list the risk of bone fracture around the implant in revision D of the instructions for use. The instructions for use have since been updated to revision E, which now reflects the risk of periprosthetic femoral (thigh) bone fracture.
• Based on a recent review of patients in the United Kingdom implanted with the CPT Femoral Stem, approximately 1.4% of patients experienced a femoral (thigh) bone fracture after surgery, and similar PTS Hip Stems have PFF rates ranging from approximately 0.6% to 1%. The full message from the United Kingdom health authority can be found at:
• Patients should be aware of the increased risk of femoral (thigh) bone fracture after surgery with the CPT Hip System.
• If fracture of the femoral bone occurs, an additional surgery is typically required to repair the bone and potentially replace the femoral stem implant.ÌýÌý If you have been experiencing any new pain, difficulty when walking, inability to bear weight, swelling or instability of the hip, it is recommended that you follow-up with your surgeon or another health care provider for further evaluation.Ìý
• Patients should continue normal follow-up with their surgeon or health care provider unless experiencing unexpected symptoms.
• The fact that a patient has a hip component within the scope of this notice does not necessarily mean that the hip component is not functioning well or needs to be replaced or removed.Ìý
• Removal of any hip arthroplasty when a patient is not experiencing any symptoms is not recommended.Ìý
• Questions regarding the CPT Femoral Stem or any other 91³Ô¹ÏÍø’s hip products should be directed to the 91³Ô¹ÏÍø Customer Service Team at 574-371-3071.ÌýÌý
• Complaints related to the CPT Femoral Stem or any other 91³Ô¹ÏÍø hip products can be reported to 91³Ô¹ÏÍø’s Post-Market Surveillance Department at product.experience@zimmerbiomet.com for investigation, potential regulatory reporting and monitoring.
• For your reference, the item list for the affected CPT Femoral Stem products is provided in Table 1. You may refer to your health care provider or surgery center to obtain your operation implant information records to identify the item numbers.
• Patient health and safety are top priorities at 91³Ô¹ÏÍø. We appreciate your time and attention in reading this important information.