In October, Stryker issued a Safety Communication related to STAR Total Ankle Replacement Non-Foil Packed Mobile Bearing Components due to a higher than expected risk of polyethylene fracture of certain sliding core components.
The company learned that patients implanted with STAR distributed before August 2014 may experience a higher than expected risk of polyethylene fracture due to a potential increase in polyethylene oxidation before or after implantation, and potentially due to implant geometry. Additional factors include component malalignment, surgeon learning curve, and reduced insert thickness.
The communication was issued after identification of a 13.79% polyethylene fracture rate at an eight-year follow-up in a post-approval study, and over 100 polyethylene fractures reported in FDA’s Medical Device Reporting database. Both occurred substantially more often than with comparable total ankle systems and with fixed-bearing total ankles.
The polyethylene component of STAR manufactured and distributed after August 1, 2014, is excluded from the communication.
Potential risks associated with a broken mobile bearing, such as loss of mobility, soft tissue injury, damage to the metal components of the device, etc., may lead to the need for revision surgery.
In October, Stryker issued a Safety Communication related to STAR Total Ankle Replacement Non-Foil Packed Mobile Bearing Components due to a higher than expected risk of polyethylene fracture of certain sliding core components.
The company learned that patients implanted with STAR distributed before August 2014 may experience a higher than...
In October, Stryker issued a Safety Communication related to STAR Total Ankle Replacement Non-Foil Packed Mobile Bearing Components due to a higher than expected risk of polyethylene fracture of certain sliding core components.
The company learned that patients implanted with STAR distributed before August 2014 may experience a higher than expected risk of polyethylene fracture due to a potential increase in polyethylene oxidation before or after implantation, and potentially due to implant geometry. Additional factors include component malalignment, surgeon learning curve, and reduced insert thickness.
The communication was issued after identification of a 13.79% polyethylene fracture rate at an eight-year follow-up in a post-approval study, and over 100 polyethylene fractures reported in FDA’s Medical Device Reporting database. Both occurred substantially more often than with comparable total ankle systems and with fixed-bearing total ankles.
The polyethylene component of STAR manufactured and distributed after August 1, 2014, is excluded from the communication.
Potential risks associated with a broken mobile bearing, such as loss of mobility, soft tissue injury, damage to the metal components of the device, etc., may lead to the need for revision surgery.
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