Stryker Orthopaedics has issued a voluntary recall of its Rejuvenate Modular and ABG II modular-neck hip stems. According to its website, the company is voluntarily recalling the Rejuvenate Modular and ABG II modular-neck hip stems over fears that the metal-on-metal hip components increase the risk of corrosion and subsequent tissue damage.
The use of modular necks was intended to allow greater technical precision when operating on artificial hip recipients, according to clinical information funded by Stryker. However, the risk of metal corrosion linked to such devices has called their safety into question. Stryker has voluntarily recalled the modular neck hip stems “because there is a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.” These complications may manifest as pain and/or swelling in patients, the company stated on their website.
This is not Stryker’s first recall over metal-on-metal hips. In April, the company recalled the MITCH TRH modular head/acetabular cup used in combination with the Accolade femoral stem due to significantly high revision rates.
Stryker’s recall is representative of the safety concerns with all metal-on-metal hip replacement systems. The implants use all metal components, which can release metal ions when they rub together. The devices have been linked to high failure rates, pseudotumors, metallosis, bone loss, soft tissue reactions and other complications.