Over the past few years, various orthopedic surgeons around the country and their patients have been faced with a catastrophic failure of Stryker’s Accolade and V40 LFIT hip implants and incredible challenges for the patients.

In June of 2014, orthopedic surgeons from New England Baptist Hospital in Boston, Massachusetts (Dr. Carl T. Talmo) and Hinsdale Orthopedic Associates located near Chicago, Illinois (Dr. James V. Bono), both consultants for Stryker, wrote about their experiences with three patients who experienced dissociation of their Stryker hip implants.

The surgeons noted in their published paper that they were aware of the potential of increased fretting, crevice corrosion, and generation of metal ions in patients with metal-on-polyethylene modular Stryker Accolade implants at the junction between the metal head and the trunnion of the stem (commonly referred to as the Morse taper connection), especially with larger femoral heads due to the potential for greater torque. They reported, however, that they did not expect for patients to experience a spontaneous dissociation of the modular hip implant, which is a very rare event and usually associated with trauma, and were of the belief that the 3 cases documented in their paper might be the first reported cases of spontaneous dissociation of a modular head used in a total hip arthroplasty in the absence of trauma or breakage of the component.

Below is a summary of the spontaneous dissociation events (characterized as dissociation with associated severe trunnion wear, fretting, and corrosion) suffered by patients in these two orthopedic surgery practices:

• Accolade Patient #1 – A Seventy-eight year old male was implanted with a Stryker Accolade TMZF stem with a 36-mm +5 offset chrome-cobalt head and a cementless hemispheric titanium Stryker Trident shell with a Stryker Crossfire cross-linked polyethylene liner and had an uncomplicated recovery from the initial total hip arthroplasty. The patient followed up with his surgeon on a regular basis for five years, and showed no signs on physical examination or on x-rays or other diagnostic testing of bone loss, loosening of the implant, or subsidence of the stem. About seven years after placement of the Stryker Accolade hip implant, the patient experienced groin pain and a grinding sensation in his hip for 2 to 3 weeks before the dissociation occurred. During the patient’s revision surgery, it was noted that the trunnion had severe corrosion with the presence of significant metal debris in the hip joint. The trunnion was reportedly too deformed and damaged to be salvaged and the plastic liner of the Accolade hip implant was also unable to be reused in the revision surgery due to severe scratching and deformity of the liner. Laboratory testing of the femoral component of the Stryker Accolade hip implant noted severe corrosion of the trunnion taper.
• Accolade Patient #2 – A 74-year old man underwent a minimally-invasive total hip replacement surgery with placement of a 58-mm Stryker Trident shell, neutral Stryker Crossfire 36-mm cross-linked polyethylene liner, a size 3.5 Accolade TMZF stem, and a Stryker 36-mm +5 chrome-cobalt femoral head. The patient did well for about 6 ½ years, at which time he developed groin pain that was especially prominent with walking and weight bearing. The patient had no history of trauma or change in his activities, and had been active prior to that without a limp or other limitations. X-rays taken at that time showed a dissociation of the femoral head from the trunnion, which essentially is a collapse of the device components. During the surgery to remove the failed Stryker Accolade modular hip prosthesis components, the surgeon noted the presence of metallic-stained fluid, significant metal wear debris, inflammatory tissue, and numerous irregularities in the trunnion (corrosion, severe, deformities in the metal, and deep grooves). The patient also had elevated levels of cobalt and chromium in his bloodstream.
• Accolade Patient #3 – A 68-year old patient was implanted with a Stryker Accolade TMZF stem as well as a modular Stryker 36-mm +10 cobalt-chrome head and reportedly had an uneventful, pain free experience with the hip implant for the first 7 years following implantation. The patient then suffered a spontaneous dissociation of the Stryker Accolade hip implant with a metal head that was similar to the surgeons’ experiences with Patients #1 and #2 with regard to the rapid onset of symptoms as well as intra-operative findings following the dissociation of the Stryker Accolade hip implant.

In this published article from Drs. Talmo and Bono, the surgeons noted that all 3 patients had the same tapered femoral component (which is made of a beta-titanium alloy) and all three patients’ Stryker Accolade devices were placed with a high-offset, long-angle neck, which they speculated may have played a role in the catastrophic failure of the implants in these patients. They also cited to previous scientific publications that questioned whether the geometry of the modular components was playing a role in increased fretting and corrosion as well as how greater movement and torque of the device might lead to failure of the trunnion.

The surgeons also speculated about whether the use of different metals for the components used by Stryker might have contributed to the corrosive process, and questioned whether the force of impaction used during the index surgery to place the femoral head might allow fluid and tissue debris to enter into a gap between the connections of the modular components. The surgeons asked for more research on the use of Morse taper junctions in hip implants as well as an inquiry into surgical techniques in hopes of avoiding more spontaneous dissociation injuries to patients in the future.

We have been investigating, blogging and publishing on this very issue since 2014. A very detailed analysis has been performed on the failed, explanted devices.

In our opinion, this problem is widespread and the three cases these doctors discuss are the tip of the Stryker L-Fit V40 and Accolade stem failure iceberg.