STAR™ 400-143FRecalls & reported problems
Stryker GmbH · Sliding Core, UHMPWE, 9mm · Class 3 · Implant
All models of STAR (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886385026954), received between Jun 12, 2018 and Apr 20, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Fracture2
- Material Deformation1
- Naturally Worn1
- Unstable1
Patient problems
- Failure of Implant2
- Insufficient Information2
- Cyst(s)1
- Discomfort1
- Implant Pain1
- Joint Laxity1
- No Information1
- Pulmonary Embolism1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24933084 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 25, 2026Unstable
REVISION SURGERY - DUE TO INSTABILITY AND WEAR.
Patient problems: Joint Laxity
MAUDE report 24683611 ↗InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A LATERAL GUTTER DEBRIDEMENT A POLY SWAP TOOK PLACE.
Patient problems: Insufficient Information
MAUDE report 16057163 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE (B)(6) 2022 A STRYKER DJO F&A SALES SUPPORT SPECIALIST RECEIVED AN E-MAIL REGARDING A STAR ANKLE POLY SWAP REVISION SURGERY AT (B)(6) CENTER WITH DR. (B)(6) ON A (B)(6) YEAR OLD MALE PATIENT. IT WAS STATED THAT THE "SURGERY WAS ADDRESSING CYSTS AND POLY WAS SWAPPED" AND THAT THE SURGERY WAS COMPLETED AS INTENDED.
Patient problems: Cyst(s)
MAUDE report 13861940 ↗InjuryJul 7, 2021Fracture; Fracture
IT WAS REPORTED THE POLY BROKE DOWN, CAUSING DISCOMFORT. A REVISION SURGERY WAS PERFORMED.
Patient problems: Discomfort; Failure of Implant
MAUDE report 12127571 ↗InjuryJun 9, 2021Fracture; Fracture
IT WAS REPORTED THE POLY SNAPPED IN HALF. A POLY EXCHANGE WAS PERFORMED.
Patient problems: Failure of Implant
MAUDE report 11966809 ↗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 10805484 ↗InjuryMar 14, 2019Material Deformation; Naturally Worn; Material Deformation
A STAR ANKLE POLY SWAP WAS REPORTED DUE WEAR ON INSERT.
Patient problems: No Information
MAUDE report 8422648 ↗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 7593468 ↗
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 400-254Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained7 reports
- STAR 400-262Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained6 reports
- STAR 400-264Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained5 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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