STAR™ 400-253Recalls & reported problems
Stryker GmbH · Talar Component, Single Coated/US Version X-SMALL, LEFT · Class 3 · Implant
All models of STAR (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886385016443), received between Jun 12, 2018 and Nov 24, 2020 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pulmonary Embolism1
- Thrombosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT HAD OSTEOPHYTES WHICH CAUSED MEDIAL IMPINGEMENT. SUBJECT HAD OSTEOPHYTES REMOVED ON (B)(6) 2018 IN WHICH THE AE RESOLVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10892093 ↗InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA AN ADVERSE EVENT REPORT (ANKLE STAR STUDY) THAT THE SUBJECT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018, SEVEN DAYS POST-OP OF A STAR IN LEFT ANKLE ON (B)(6) 2018. THE SUBJECT WAS DIAGNOSED WITH BILATERAL SECOND AND THIRD ORDER PULMONARY EMBOLI. ULTRASOUND OF RIGHT LEG SHOWED AN INFRAPOPLITEAL TIBIAL VEIN THROMBUS. NO THROMBI ABOVE THE KNEE FOUND IN EITHER LEG. THE LEFT LOWER LEG COULD NOT BE SOUNDED BECAUSE OF WOUND DRESSING. SUBJECT WAS PRESCRIBED WITH AN ANTICOAGULATION OF ELIQUIS 10MG. PATIENT WAS DISCHARGED ON (B)(6) 2018 AND EVENT IS CONTINUING WITH TREATMENT".
Patient problems: Pulmonary Embolism; Thrombosis
MAUDE report 7593466 ↗
Other Prosthesis, Ankle, Uncemented, Non-Constrained devices
- STAR 400-140FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained27 reports
- STAR 400-141FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained24 reports
- STAR 400-142FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained23 reports
- STAR 400-144FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR 400-263Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR™ 400-143FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained10 reports
- STAR 400-254Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained7 reports
- STAR 400-262Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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