Stryker Expands On Reasons for All-Metal Hip Recall
July 10th, 2012 tmccoy
Strkyer has officially recalled a pair of metal-on-metal (“MoM”) hip implants containing Rejuvenate Modular and ABG II modular-neck hip stems after post-market surveillance data suggests that the devices suffer “fretting and/or corrosion at or about the modular-neck junction.”
The modular-neck stems at issue do provide a more natural hip geometry that assists physicians during surgery and would ideally benefit patients thereafter. Nevertheless, Stryker officials confirmed that, “[w]hile 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.”
A previous Stryker report conceded that the fretting and corrosion issue is a real threat, and even went so far as to admit that “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.”
Stryker’s voluntary recall comes after concerns that negative “post-market surveillance data may be predictive of a trend.” Unfortunately, it will likely take additional time for this potential trend to materialize and other device manufacturers to follow suit.
