Risk of Device Component Breaking in Patients with Stryker's ... | 合法醫療器材資訊網
2021年3月15日—TheSTARAnkleisindicatedforuseasanon-cementedtotalankleprosthetic(“artificialjoint”)andusedtoreplaceapainfularthriticankle ...
October 1, 2021 Update: The final data
summary for the long-term post-approval study results can be
found on the post-approval
study webpage[1]. The
product labeling was updated to include these results and to
include the potential risk of plastic component fracture.
Date Issued: March 15, 2021
The U.S. Food and Drug Administration (FDA) is advising patients, caregivers, and health care providers about the higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as three to four years after implantation in all Scandinavian Total Ankle Replacement devices (STAR Ankle). Fracture of the plastic component of the STAR Ankle may lead to surgery to repair or replace the device.
Based on the FDA’s recent analysis of FDA-required post approval studies[2] and adverse event reports, the potential risk of the ...
STAR | 合法醫療器材資訊網
Total Ankle Replacement | 合法醫療器材資訊網
STAR Total Ankle Replacement | 合法醫療器材資訊網
STAR™ Total Ankle Replacement | 合法醫療器材資訊網
Risk of Device Component Breaking in Patients with Stryker's ... | 合法醫療器材資訊網
STAR™ | 合法醫療器材資訊網
The STAR Ankle Replacement | 合法醫療器材資訊網
Stryker Foot and Ankle | 合法醫療器材資訊網
Prospective controlled trial of STAR total ankle replacement ... | 合法醫療器材資訊網
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