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Risk of Device Component Breaking in Patients with Stryker's ... | 合法醫療器材資訊網

Risk of Device Component Breaking in Patients with Stryker's ...

2021年3月15日—TheSTARAnkleisindicatedforuseasanon-cementedtotalankleprosthetic(“​artificialjoint”)andusedtoreplaceapainfularthriticanklejoint ...

 Risk of Device Component Breaking in Patients with Stryker's ...

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 ...

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STAR | 合法醫療器材資訊網
The Scandinavian Total Ankle Replacement (STAR™ Ankle) is intended for use as a non-cemented implant to replace a painful arthritic ankle joint due to ... Read More
Total Ankle Replacement | 合法醫療器材資訊網
The STAR total ankle is the only PMA approved mobile bearing total ankle in the U.S. market that is approved for uncemented use. The animation video outlines ... Read More
STAR Total Ankle Replacement | 合法醫療器材資訊網
The Scandanavian Total Ankle Replacement (STAR™ Ankle) was designed to replace ankle joints that have been compromised and have become painful ... Read More
STAR™ Total Ankle Replacement | 合法醫療器材資訊網
The Scandinavian Total Ankle Replacement (STAR Ankle) is intended for use as a non-cemented implant to replace a painful arthritic ankle joint due to ... Read More
STAR™ | 合法醫療器材資訊網
The Scandinavian Total Ankle Replacement (STAR™ Ankle) is intended for use as a non-cemented implant to replace a painful arthritic ankle joint due to ... Read More
STAR Total Ankle Technique Video | 合法醫療器材資訊網
2016年9月1日 — Video is a replication of the surgical technique used to complete the STAR Total Ankle. The procedure was performed in a cadaveric specimen ... Read More
Stryker Foot and Ankle | 合法醫療器材資訊網
2016年4月29日 — The STAR total ankle is the only PMA approved mobile bearing total ankle in the US market that is approved for uncemented use. Read More
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 — The STAR Ankle is indicated for use as a non-cemented total ankle prosthetic (“​artificial joint”) and used to replace a painful arthritic ankle joint ... Read More
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