STAR™ 400-252Recalls & reported problems
Stryker GmbH · Talar Component, Single Coated/US Version X-SMALL, RIGHT · Class 3 · Implant
All models of STAR (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886385016436), received between Nov 6, 2020 and Apr 19, 2021 — classified as 3 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 Problem3
Patient problems
- Unspecified Infection2
- Impaired Healing1
- Implant Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED." PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON (B)(6) 2021 THE EVENT IS AS FOLLOW: 15 JUL 2015: ANTERIOR ANKLE ARTHROTOMY WITH REMOVAL OF TOTAL ANKLE IMPLANT WITH BONE CULTURE AND BIOPSY. ¿ 5TH INTERVENTION.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 11689410 ↗InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED". PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON MARCH 25TH, 2021 THE EVENT IS AS FOLLOW: (B)(6) 2015 : LATERAL ANKLE ARTHROTOMY WITH BONE CULTURES AND IRRIGATION OF RIGHT ANKLE - 2ND INTERVENTION.
Patient problems: Unspecified Infection
MAUDE report 11679399 ↗InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "ANKLE PAIN. EXPLANTATION OF STAR TOTAL ANKLE AND REVISION TO TTC."
Patient problems: Implant Pain
MAUDE report 10805483 ↗
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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