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Stryker Report Finds Hip Implant Modular Neck Stem Pose Metal Ion Risks

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A Stryker report finds that hip implant modular neck stems pose metal ion risks. Not surprising, given that, more-and-more, tests are revealing that patients implanted with metal-on-metal hip replacement devices are suffering from increased metal ion levels that have led to metallosis, pain, and masses in the area surrounding the implants.

Device maker, Stryker, just released a report regarding the continuing debacle surrounding metal-on-metal implants, said Mass Device. The controversy led to regulatory investigations following a global recall by Johnson & Johnson’s DePuy Orthopaedics unit over a higher-than-expected failure rate in its hip implant device systems.

The report discusses modular neck stem benefits, but notes that, in some cases, the stems are associated with the same issues as what has been seen in metal-on-metal hip devices, said Mass Device.

“In vivo production of metal debris from implants has been the subject of much scrutiny recently. Metal on metal bearings, for example, produce small (20-80nm diameter) metallic wear debris whenever motion is present,” the report stated. “Elevated blood serum metal ion levels (it is believed these metal ions are produced by corrosion of the wear debris in the case of metal on metal joints) and metal hypersensitivity resulting in an adverse local tissue reaction may occur with metal-metal articular surface bearings, causing premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation,” the report continued, said Mass Device.

Stryker issued another metal-on-metal hip implant warning in April. Stryker contraindicated its Accolade femoral stems against use with Mitch TRH acetabular cups and Mitch TRH modular heads, which were manufactured by DePuy’s Finsbury Orthopaedics unit, Mass Device pointed out.

Now, Stryker is recalling two metal hip implant components, stopping worldwide production of the devices after discovering the potential for “fretting and/or corrosion” that could lead to pain, swelling, and tissue damage, said Mass Device. Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems, are being recalled following “continued post-market surveillance,” said the firm’s press release. “The post-market surveillance data may be predictive of a trend.”

“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” hip reconstruction vice president and general manager Stuart Simpson said in prepared remarks, wrote Mass Device.

Modular neck stems enable surgeons to better copy a patient’s natural hip geometry and “can facilitate femoral component insertion in more technically challenging surgical approaches,” said the 2012 Stryker report. The neck stems, however, have also been associated with sensitivity resulting from metal corrosion, said Mass Device.

Stryker also indicated, said NewsInferno, patients who have received the recalled Stryker hip implant components should schedule a visit with their surgeon if they experience symptoms typical of a malfunctioning hip implant. Patients without symptoms should continue to follow the post-operative plan their surgeon outlined. Affected patients may experience pain and/or swelling at the joint site.

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