STAR 920-0061Recalls & reported problems
Stryker GmbH · TIBIAL BARREL IMPACTOR · Class 3
All models of STAR (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886385017983), received between Oct 15, 2018 and Dec 17, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Most reported problems
Device problems
- Break3
- Fracture2
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2019Fracture; Fracture
THE CUSTOMER REPORTS A BREAKAGE OF THE TIBIA-IMPACTOR OF THE STAR-PROTHESIS. REPLACEMENT WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9482051 ↗MalfunctionMay 31, 2019Break
STRYKER KIT INSPECTION SPECIALIST REPORTED THAT IN MOST CIRCUMSTANCES WHEN THE STAR TIBIAL IMPACTOR RETURNS IN A KIT FROM THE CUSTOMERS, THE PLASTIC ELEMENT IS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8660744 ↗MalfunctionMar 19, 2019Break; Fracture; Fracture
UPON INCOMING INSPECTION IT WAS NOTICED THAT THE DEVICE WAS BROKEN AND UNUSABLE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8434717 ↗MalfunctionOct 15, 2018Break
AS REPORTED: "BLACK PIECE ON THE INSERTER BROKE AS THE SURGEON TRIED TO IMPLANT THE TIBIAL COMPONENT. INSERTER WAS REMOVED AND THE SURGEON USE THE JOINT SPACE EVALUATOR TO PUSH AND IMPLANT THE TIBIAL COMPONENT. NO ADVERSE CONSEQUENCES. HOWEVER, IT DELAYED THE CASE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7966722 ↗
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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