Stryker Rejuvenate and ABG Hip Implants

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The Stryker Rejuvenate system was approved by the FDA in June 2008 and the ABG II system was approved in November 2009. Unlike many hip implant systems, Stryker’s Rejuvenate and ABG II systems include several neck and stem components. The purpose was to provide surgeons with greater flexibility. The rejuvenate system was targeted towards younger patients looking for a system that would provide greater survivorship.

Tellingly, in April 2012, Stryker issued an “urgent safety alert” to surgeons and hospitals alerting them to the side effects associated with these two systems. Namely, the excessive metal ions and metal debris which has plagued metal-on-metal hip implants since their introduction to the market. But also, the corrosive and fretting effect of the neck junction which may lead to “increased metal ion generation in the surrounding joint space.”

The urgent alert comes in the wake of a study published in the Journal of American Academy of Orthopaedic Surgeons in April 2012 warning that corrosion is a reason for failure of modular implants. Specifically, the study found that there is an increased concern for component failure through taper fretting, fatigue fracture and corrosion, all of which can lead to elevated metal ion levels.

On May 28, 2012, the Stryker Rejuvenate system was recalled in Canada so that the instructions for use could be updated. In July 2012, Stryker issued a recall of both the Rejuvenate and ABG II modular neck stems. Reportedly, the FDA obtained more than 60 adverse event reports related to these hip implants. Some of the adverse events related to metal debris and one of them involved the removal of the implant.

Since the recall, the company has advised patients to see their surgeon to have blood levels tested for metal ions and to also undergo X-Rays and MRIs to monitor the hip implants. Some of the common side effects and complications that might arise from having a Stryker Rejuvenate or ABG II metal-on-metal hip implant include:

  • Increased levels of metal ions
  • Increased metal wear rates which may cause metal debris
  • Fretting debris
  • Osteolysis
  • Necrosis- death of the tissue surrounding the implant
  • Severe hip pain due to dislocation or metal wear
  • Revision surgery- surgery to remove the failed metal-on-metal hip implant
  • Local adverse tissue reactions

Metal-on-metal hip implants continue to pose a serious health risk to patients. The FDA recently asked 21 manufacturers to monitor the metal ion levels of patients implanted with metal-on-metal hip devices.

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