STAR 400-255Recalls & reported problems
Stryker GmbH · Talar Component, Single Coated/US Version SMALL, LEFT · Class 3 · Implant
All models of STAR (22)
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 00886385016467), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.
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 Problem1
Patient problems
- Failure of Implant1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT RECEIVED STAR IN THE LEFT ANKLE ON (B)(6) 2018 FOR PRIMARY ARTHROSIS, WITH LEFT GASTROCSOLEUS RECESSION, LEFT DISTAL TIB/FIB FUSION, LEFT PLACEMENT OF MEDIAL MALEOLAR SCREWS FOR PROPHYLAXIS FOR IMPENDING MEDIAL MALLEOLAR FRACTURE, AND A SEPARATE INCISION FOR LEFT SECONDARY LATERAL LIGAMENT RECONSTRUCTION. SUBJECT WAS CONTACTED FOR FOLLOW-UP AND STATED THAT SHE HAD HER LEFT ANKLE REPLACEMENT REMOVED ON [ (B)(6) 2020] DUE TO DEVICE FAILURE. AE ONSET DATE WAS 12DEC2019. THE INVESTIGATOR DEEMED THIS AE AS SEVERE WITH UNKNOWN RELATIONSHIP TO THE DEVICE AT THE TIME OF THIS REPORTING. AS OF THE TIME OF THIS REPORT, THIS ADVERSE EVENT IS RECOVERED WITH TREATMENT (SURGERY: REVISION/REMOVAL OF STAR)."
Patient problems: Failure of Implant; Injury
MAUDE report 9838135 ↗
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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