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Zimmer ProxiLock Hip Prosthesis

Zimmer manufactures personalized joint replacement technology. One of the company's products, the Proxilock Hip Prosthesis, is used for total hip replacements. Studies show this device can increase the risk of femur fracture.

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The Zimmer ProxiLock Hip Prosthesis is a metal stem that is inserted into the hollow center of a thighbone, the femur, as part of a total hip replacement procedure. This stem serves to anchor a prosthetic femoral head, or ball, at the top of the thighbone, which then fits into the socket on the pelvis called the acetabulum. 1

The hip joint is formed where the thighbone meets the pelvis. As with other joints, this type of ball-and-socket hip joint can cause significant pain when damaged by trauma or diseases over time, such as osteoarthritis. 2

In a healthy hip joint, the surfaces of the bone are covered with cartilage, which cushions the ends of the bones. In addition, a thin tissue called the synovial membrane produces a type of fluid that lubricates the cartilage. Together, they allow the hip to move freely and painlessly. 3

In an individual with osteoarthritis, the cartilage has become damaged and worn out, causing friction and pain. Bone spurs may also form where bone rubs against bone. The end result may be debilitating pain and loss of mobility. 4

Zimmer Hip Replacement Surgery

When medicine, exercise, and physical therapy no longer help, doctors may suggest a total hip replacement. During this surgical procedure, called a total hip arthroplasty, the surgeon removes the damaged bone and cartilage and replaces them with prosthetic parts. 5

Prosthetic hip devices require two major parts: the femoral head and its stem, and a pelvic socket. Generally speaking, there are two areas that need to be repaired in total hip replacement surgery: the socket in the pelvis and the ball at the top of the thighbone. 6

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ProxiLock Hip Prosthesis Implant

Zimmer has a variety of prosthetic devices designed to replace damaged joints. The ProxiLock Hip Prosthesis is one such device that is used in a total hip replacement procedure. 7

According to the original 510(k) application, the ProxiLock Hip Prosthesis can be implanted when “reconstructing the hip joint on the femoral side.” The Zimmer stem on this particular model “is intended for use in the relatively younger, moderate and higher demand patient in hybrid or cementless hip arthroplasty.” 8

The stem is the part of the prosthesis that is inserted into the femur.

The researchers, Watts et al., found that the hydroxyapatite-coated Zimmer ProxiLock Hip Prosthesis stem, by their assessment, has “a uniquely exaggerated proximal taper angle” and, based on their study results, appears to have “an increased risk of both early and late postoperative periprosthetic femur fracture.”

Study Reports Concern with Zimmer ProxiLock Hip Prosthesis

A study in the journal Clinical Orthopaedics and Related Research suggests Zimmer’s hydroxyapatite-coated ProxiLock Hip Prosthesis stem may lead to increased risk of femur fracture requiring reoperation or revision.

The researchers, Watts et al., found that the hydroxyapatite-coated Zimmer ProxiLock Hip Prosthesis stem, by their assessment, has “a uniquely exaggerated proximal taper angle” and, based on their study results, appears to have “an increased risk of both early and late postoperative periprosthetic femur fracture.” In addition, “[t]he majority of patients with a fracture underwent reoperation or stem revision.” 9

Total Hip Replacement Procedure

Different manufacturers offer a variety of prosthetic hip replacement systems, but they function in a similar manner. During the hip replacement procedure, the surgeon removes the damaged femoral head (ball) on the thighbone and any worn cartilage. 10

Then the surgeon inserts the metal stem of the prosthesis into the hollow center of the femur. The stem may be either cemented or “press fit” into the bone. 11

Next, the surgeon places either a metal or ceramic ball on the upper part of the stem. This prosthetic head will be what fits into the new socket on the pelvis. 12

The surgeon will take similar steps to remove and replace the damaged pelvic socket (acetabulum). This part of the prosthesis may be screwed in or cemented to hold the socket in place. 13

The surgeon will then insert a plastic, ceramic or metal spacer between the new ball and new socket to create a smooth, freely moving surface. 14

  1. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.zgreatlakes.com/Literature/Hips%20Brochure/97-4111-001-00%20Proxilock_Hip_Prothesis_Brochure.pdf 

  2. http://www.orthop.washington.edu/?q=patient-care/articles/hip/what-is-hip-replacement-a-review-of-total-hip-arthroplasty.html; http://orthoinfo.aaos.org/topic.cfm?topic=a00377 

  3. http://www.orthop.washington.edu/?q=patient-care/articles/hip/what-is-hip-replacement-a-review-of-total-hip-arthroplasty.html; http://orthoinfo.aaos.org/topic.cfm?topic=a00377 

  4. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://nihseniorhealth.gov/hipreplacement/whoneeds/01.html; http://www.mayoclinic.org/tests-procedures/hip-replacement-surgery/basics/definition/prc-20019151  

  5. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.niams.nih.gov/health_info/hip_replacement/; http://www.mayoclinic.org/tests-procedures/hip-replacement-surgery/basics/definition/prc-20019151 

  6. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241594.htm 

  7. 2002-10-02 510(k) ProxiLock K022966.pdf;

  8. 2002-10-02 510(k) ProxiLock K022966.pdf http://www.zgreatlakes.com/Literature/Hips%20Brochure/97-4111-001-00%20Proxilock_Hip_Prothesis_Brochure.pdf 

  9. http://www.ncbi.nlm.nih.gov/pubmed/25502478 

  10. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241594.htm;  

  11. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://orthopedics.about.com/od/hipkneeimplants/f/fixation.htm; http://www.arthritis-health.com/surgery/hip-surgery/total-hip-replacement-surgical-procedure  

  12. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.arthritis-health.com/surgery/hip-surgery/total-hip-replacement-surgical-procedure 

  13. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.arthritis-health.com/surgery/hip-surgery/total-hip-replacement-surgical-procedure 

  14. http://orthoinfo.aaos.org/topic.cfm?topic=a00377; http://www.arthritis-health.com/surgery/hip-surgery/total-hip-replacement-surgical-procedure