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Stryker Tritanium Acetabular Shells

Some patients have experienced significant problems with Stryker Tritanium Acetabular Shells following total hip replacement surgery. These shells, or cups, may loosen shortly after initial (index) surgery, leading to revision surgery. This complication is considered primary hip replacement failure.

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Experienced complications related to Stryker Tritanium Acetabular Shells?

Stryker Tritanium Acetabular Shells include Stryker’s Trident Tritanium Acetabular System for hip replacement. This component replaces a damaged or diseased hip socket.

According to the manufacturer, these Tritanium Stryker Acetabular Shells are intended for use due to (1):

  • Painful, disabling hip joint disease and damage, including some forms of arthritis.
  • Revision of failed previous hip replacement procedures.
  • Hip joint damage when the natural bone is not healthy or there is not enough healthy bone to work with.
  • Medical conditions that require hip joint repair for which other surgical options may be less effective.

Stryker Tritanium Uses Titanium Alloy

Stryker’s Tritanium Acetabular Shell was introduced to the U.S. market in 2008. These hip replacement components are made of a titanium alloy and coated with a porous substance called “particle sintered foam.” (2)

Research and adverse event reports suggest these Stryker Tritanium Acetabular Shells can loosen within months of initial implantation, leading to early hip implant failure.

Stryker Hip Replacement System Studies Raise Concern

Researchers have found that patients implanted with Stryker Tritanium Acetabular Shells have had early loosening and failure of these components.

Patients May Experience Early Loosening

In one study, 95 patients received 109 total hip replacements in which a Tritanium acetabular component was used. They underwent their surgeries from 2008-2009. (3)

The researchers followed up with these patients at several intervals — 6 weeks, 3 months, 1 year, 2 years, and 5 years. The researchers wanted to see how patients were doing with their Stryker Tritanium hip replacement implants. The researchers took x-rays of each patient’s hips at, at least, the six-week and one-year follow-up appointments.

The researchers looked on the x-rays for radiolucent lines around the acetabular cups and sclerotic changes. Basically, they wanted to see if each patient’s own bone had grown into the implant to give it stability. Dark areas surrounding the implant that measured a certain length and width could suggest the implant was loose and not integrating properly with the patients’ bone.

These researchers were concerned with what they found. More than one-third of these patients showed signs of hip implant acetabular cup loosening within just 5 years. The researchers recommended additional studies be done and said they would continue to follow up with these patients to see how they were doing.

A year later, in 2018, these researchers published an additional paper reaffirming their initial findings. They suggested doctors continue to follow up with patients who had received a Stryker Tritanium primary acetabular cup implant. The researchers said orthopedists should look for evidence of clinical deterioration (an increase in patient symptoms, such as groin or hip pain) and implant loosening. (4)

Suffering Due to Hip Replacement Failures

In another study, researchers at NYU Langone Orthopedic Hospital identified five patients who had been implanted with a Tritanium acetabular cup during primary hip replacement surgery and undergone revision hip replacement surgeries. These revisions were all due to loosening of the Stryker Tritanium acetabular cup component within months after initial implantation. (5)

All five of the patients had undergone a primary total hip replacement surgery between 2011 and 2016. The patients were between 48 and 68 years of age.

Each of these patients received a Stryker Tritanium hip implant with screw fixation. The screws were supposed to supplement the implant’s stability. Ultimately, however, in spite of the screws, the Tritanium acetabular cups failed to integrate into the patients’ pelvic bones. The patients presented to their physicians with hip or groin pain within months of their initial surgery. When their surgeons performed revision surgery on the patients’ hips, they found failure of bony ingrowth in all of the hips.

These researchers’ findings supported those found by other researchers. The researchers also recommended that more studies be conducted regarding the overall safety of Stryker’s Tritanium primary cup in total hip replacement procedures.

Loosening Adverse Event Reports

In addition to medical literature, adverse event have been reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database describing similar complications. (6) (7) (8) (9) (10)

Like the cases described in the medical literature, many reports in the MAUDE database describe failure of Tritanium acetabular cups due to loosening, with orthopedic surgeons often observing failure of bony ingrowth (osseointegration) during revision surgery.

Total Hip Replacement

Total hip replacement can be an effective treatment for degenerative hip diseases, trauma, or other hip joint damage. Patients should expect their hip implant devices to decrease their pain and improve their function.

Overall, total hip replacement procedures are considered highly successful orthopedic procedures. Hundreds of thousands of total hip replacements are performed each year. By 2030, more than a half a million people may undergo total hip replacement surgery. (11)

Successful total hip replacement procedures often last for years. Some sources have estimated, for cementless acetabular cups with screw fixation, survival rates exceeding 90% after 10 years and 85% after 15 years. (12)

Hip Revision Surgery May Be Needed

However, not every patient experiences a successful total hip replacement procedure. Some devices, such as Stryker Tritanium Acetabular Shells, may loosen. In these cases, patients may need to undergo revision surgery.

Although Stryker has issued recalls for other hip implant devices, the manufacturer has not issued one for Stryker Tritanium Acetabular Shells. However, concerns regarding Tritanium shell systems safety continue.

Patients considering undergoing a hip replacement revision procedure should discuss their treatment options with their doctor. If you have been implanted with a Stryker Tritanium acetabular cup and are experiencing symptoms of pain or difficulty walking, you might also want to consult an attorney regarding this potentially defective device.

  1. Food and Drug Administration. (2008, July 22). 510(k) Summary of Safety and Effectiveness. Tritanium®Acetabular Shell System. Retrieved from  https://www.accessdata.fda.gov/cdrh_docs/pdf8/K081171.pdf
  2. Long, W.J., et al. (2018, January 2). Early aseptic loosening of the Tritanium primary acetabular component with screw fixation. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5994600/
  3. Carli, A.V., et al. (2017, February). Short to Midterm Follow-Up of the Tritanium Primary Acetabular Component: A Cause for Concern. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/27642044
  4. Carli, A., et al. (2018, February 21). Primary Tritanium Acetabular Components Are Associated with a High Prevalence of Radiolucencies Which Compromise Clinical Function at Short Term Follow-up. Retrieved from https://online.boneandjoint.org.uk/doi/abs/10.1302/1358-992X.98BSUPP_7.ISTA2015-070
  5. Long, W.J., et al. (2018, January 2). Early aseptic loosening of the Tritanium primary acetabular component with screw fixation. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5994600/
  6. U.S. Food & Drug Administration. (2018, July 5). MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah Primary Tritanium Hemi Cluster Hole Cup 50mm Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. Retrieved from  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7663971&pc=LPH
  7. U.S. Food & Drug Administration. (2018, June 19). MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah Primary Tritanium Hemi Cluster Hole Cup 54mm Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. Retrieved from  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7616579&pc=LPH
  8. U.S. Food & Drug Administration. (2015, July 6). MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah Primary Tritanium Hemi Cluster Hole Cup 54mm Implant. Retrieved from  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4943948&pc=LPH
  9. U.S. Food & Drug Administration. (2017, March 17). MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah Primary Tritanium Hemi Cluster Hole Cup 54mm Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. Retrieved from  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6415408&pc=LPH
  10. U.S. Food & Drug Administration. (2017, January 19). MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah Primary Tritanium Hemi Cluster Hole Cup 54mm Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. Retrieved from  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6105467&pc=LPH
  11. Long, W.J., et al. (2018, January 2). Early aseptic loosening of the Tritanium primary acetabular component with screw fixation. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5994600/
  12. Ibid.