STAR 400-257Recalls & reported problems
Stryker GmbH · Talar Component, Single Coated/US Version MEDIUM, LEFT · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886385016481), received between Aug 8, 2017 and Aug 8, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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. How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
Patient problems
- Failure of Implant1
- Injury1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2017Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2014 THE PATIENT UNDERWENT A TOTAL LEFT ANKLE REPLACEMENT SURGERY. IT IS ALLEGED THAT ON (B)(6) 2015 HE TWISTED HIS LEFT ANKLE AND ON (B)(6) 2016 THE IMPLANT CAUSED INJURY TO THE PATIENT DUE TO "... HARDWARE FAILURE INVOLVING THE MEDIAL ASPECT OF THE ANKLE JOINT, FAILED TIBIAL COMPONENT RESULTING IN FAILED HARDWARE WITH MEDIAL MALLEOL OR NON UNION REQUIRING A REVISION AND REMOVAL OF SAID PRODUCT..."
Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture
MAUDE report 6775641 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page