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ProxiLock Hip Replacement News

While the Proxilock hip has not been recalled, Zimmer is no longer manufacturing the device. The company did recall its Durom Acetabular Component. The FDA provides information on metal-on-metal hip implant recalls related to Zimmer and other manufacturers.

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Study Finds Increased Risk of Femur Fracture

A 2014 study entitled “Increased Risk of Periprosthetic Femur Fractures Associated With a Unique Cementless Stem Design,” found a higher rate of femur fracture postoperatively in patients who had been implanted with a hydroxyapatite-coated Zimmer ProxiLock Hip Prosthesis stem implant.

Patients who had a stem that was hydroxyapatite coated had a femur fracture risk five times that of patients who had received other stems, according to Watts et al., the authors of the study, published in the journal Clinical Orthopaedics and Related Research. There was also a greater rate of patients who had to have hip revision surgery or reoperation after suffering a fracture, which is more complex than an initial total hip replacement surgery. 1

Zimmer Acquires Implex

The ProxiLock Hip Prosthesis stem was originally produced by the Implex Corp. In 2003, Zimmer Inc. agreed to acquire Implex and Implex became a wholly owned subsidiary of Zimmer. 2

The implant was originally manufactured by Implex Corp., and was given 510(k) approval from the U.S. Food and Drug Administration (FDA) by at least October, 2002. It was classified as a Class 2 device. 3

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Hip Implant Recalls

A recall does not necessarily mean that a particular implant needs to be removed and replaced, but as the FDA explains, it may mean “different or more frequent monitoring” for patients who have used the device or have had it implanted.

There have been recalls of hip replacements devices due to component failures.  Although the Zimmer ProxiLock Hip Prosthesis has not been recalled, Zimmer has discontinued manufacturing the device, according to the Watts et al. study. 4

Hip implants may be recalled for a variety of reasons. A recall does not necessarily mean that a particular implant needs to be removed and replaced, but as the FDA explains, it may mean “different or more frequent monitoring” for patients who have used the device or have had it implanted.

Some recalls of defective implants are:

Stryker: In November 2014, Stryker agreed to pay $1.43 billion or more to settle thousands of lawsuits from individuals who had to have revision surgeries to remove two types of recalled Stryker hip implants. Plaintiffs claimed Stryker’s Rejuvenate Modular-Neck and ABG II Modular-Neck hip implants became corroded, among other problems. In July 2012, Stryker had recalled both of these hip replacement systems, acknowledging the “potential risks associated with fretting and corrosion.” 5

Metal-on-metal systems include a ball, stem and shell. Each part is made of some combination of metals. 6

Number of Hip Replacement Surgeries Is Rising

According to U.S. News & World Report and NBC News, the number of hip replacement surgeries is rising, particularly among people 40 to 60 years old, but also among young adults in their 20s and 30s. 7

  1. http://link.springer.com/article/10.1007/s11999-014-4077-9#page-1 

  2. http://investor.zimmer.com/releasedetail.cfm?ReleaseID=123310 

  3. http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022966.pdf 

  4. http://link.springer.com/article/10.1007/s11999-014-4077-9#page-1 

  5. http://www.chicagobusiness.com/article/20141103/NEWS04/141109967/stryker-to-pay-1-43-billion-to-settle-hip-implant-cases; http://www.fda.gov/safety/recalls/ucm311043.htm;

    Smith & Nephew: On June 1, 2012, Smith & Nephew Orthopaedics voluntarily withdrew from the market the metal liners of its R3 acetabular system. These liners were linked to a higher than expected rate of revision surgeries outside of the U.S.

    DePuy:  On August 24, 2010, DePuy recalled its ASRTM total hip system. According to national joint registry data in the United Kingdom, this hip replacement system was linked to a higher-than-expected rate of revision surgeries. In January 2013, DePuy also recalled its Adept all-metal total hip replacement system, once again because of a higher than expected number of revision surgeries.

    Zimmer: On July 22, 2008, Zimmer voluntarily recalled its Durom® Acetabular Component (“Durom Cup”). The recall indicated that its “instructions for use/surgical technique instructions were inadequate.”

    Hip Replacement Systems Categories

    Your Doctor may choose to perform other procedures during your cardiac catherization.

    • Metal on plastic

    • Metal on metal

    • Ceramic on plastic

    • Ceramic on ceramic

    FDA Metal-on-Metal Hip Implant Information

    In February 2011, the FDA posted metal-on-metal hip implant information online. This allows the FDA to provide updated safety information, as well as recommendations to patients and health care providers.

    The stem sections of most hip implants, which are inserted into the thighbone to anchor the ball of the implant, are made of metal, either titanium- or cobalt/chromium-based alloys. The ball of the prosthesis is made of either metal or ceramic. ((http://bonesmart.org/hip/choosing-a-hip-implant-prosthesis/; http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241594.htm 

  6. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241601.htm 

  7. http://health.usnews.com/health-news/patient-advice/articles/2015/03/18/young-and-hip-replacements-rising-for-younger-adults; http://www.cdc.gov/nchs/data/databriefs/db186.htm; http://www.nbcnews.com/news/us-news/hips-dont-lie-replacements-rise-busy-boomers-age-n307126