STAR 400-140FRecalls & reported problems
Stryker GmbH · Sliding Core, UHMPWE, 6mm · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker STAR 400-140F is a sliding-core ankle prosthesis used in uncemented ankle replacement surgery. The 27 reports mostly describe pain and revision surgery to swap out the plastic bearing insert, sometimes for wear, loosening, or suspected infection, and some mention the implant breaking or coming apart. All 27 reports involve injuries, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00886385026923), received between Mar 4, 2019 and Apr 3, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Fracture” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Fracture5
- Patient Device Interaction Problem4
- Naturally Worn2
- Break1
- Detachment of Device or Device Component1
- Inadequacy of Device Shape and/or Size1
- Material Integrity Problem1
Patient problems
- Pain6
- Failure of Implant5
- Unspecified Infection5
- Implant Pain3
- Insufficient Information3
- Joint Laxity3
- Injury2
- Cyst(s)1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Patient Device Interaction Problem
InjuryApr 1, 2026Patient Device Interaction Problem
InjuryApr 1, 2026Patient Device Interaction Problem
InjuryMar 25, 2026Patient Device Interaction Problem
InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24671388 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24646419 ↗InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 22190808 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SUSPECTED INFECTION AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 21931584 ↗InjuryDec 11, 2023Material Integrity Problem; Material Integrity Problem
ON 11/15/2023, REGULATORY COMPLIANCE SPECIALIST WITH STRYKER, EMAILED ENVOIS REGULATORY WITH A MANUFACTURER INCIDENT REPORT (MIR) FROM THE EUROPEAN UNION MEDICAL DEVICES VIGILANCE SYSTEM REGARDING A 400-140F, SLIDING CORE, UHMPWE, THAT HAD BROKEN AND "THE PATIENT REQUIRED EMERGENCY SURGERY TO REPLACE IT".
Patient problems: Failure of Implant
MAUDE report 18302649 ↗InjuryNov 30, 2023Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable
AS REPORTED: "THE PATIENT'S ANKLE WAS UNSTABLE SO THE SURGEON CHANGED A 6MM INSERT FOR A 8MM INSERT."
Patient problems: Joint Laxity
MAUDE report 18243202 ↗InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A POLY WAS REVISED DUE TO AN ACUTE INFECTION UNRELATED TO THE IMPLANT. THERE WERE NO KNOWN COMORBIDITIES OR PATIENT NON-COMPLIANCE RESULTING IN THE ACUTE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15260995 ↗InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "INFECTION AFTER PRIOR REVISION SURGERY. POLY REMOVED. STAGED INFECTION CONTROL. REINSERTED NEW POLY TODAY."
Patient problems: Unspecified Infection
MAUDE report 12982312 ↗InjuryNov 10, 2021Break; Fracture; Break; Fracture
A REVISION SURGERY WAS REPORTED TO STRYKER - REASON FOR REVISION "FRACTURED POLY PAIN". "FRACTURED 6MM POLY REPLACED WITH A 7MM WITHOUT DIFFICULTY" "NO ABNORMALITIES, NO CONCERNS WITH THE SURGICAL SITE".
Patient problems: Failure of Implant; Implant Pain
MAUDE report 12785790 ↗InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE POLY WAS SWAPPED. NO FURTHER DETAILS REGARDING THE REVISION WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 12512403 ↗InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT CAME INTO CLINIC WITH PAINFUL TOTAL ANKLE. SURGEON DISCOVERED A BONE BRIDGE IN THE MEDIAL GUTTER. SURGEON DECIDED TO DO A POLY SWAP WHILE HE AS DOING THE GUTTER DEBRIDEMENT. NO OBVIOUS WEAR ON POLY, NO FAILURES OF IMPLANTS.
Patient problems: Implant Pain
MAUDE report 12474992 ↗InjuryAug 26, 2021Naturally Worn; Naturally Worn
AS REPORTED:"WORN POLY, EVERYTHING ELSE WAS SOLID. THE PATIENT REQUIRED A REVISION SURGERY".
Patient problems: Failure of Implant
MAUDE report 12369747 ↗InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: THE CASE WAS SCHEDULED AS RT ANKLE POLYETHYLENE EXCHANGE, MEDIAL GUTTER DEBRIDEMENT, MEDICAL MALLEOLAR SCREW PLACEMENT. THE PATIENT PRESENTED WITH A STIFF ANKLE. PATIENT WAS APPROXIMATELY EIGHT YEARS POST PRIMARY TOTAL ANKLE. POLY WAS EXCHANGED AND GUTTERS DEBRIDED.
Patient problems: Loss of Range of Motion
MAUDE report 12277274 ↗InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WAS 9 MONTHS POST-OP FROM PRIMARY STAR ANKLE REPLACEMENT. THE PATIENT DEVELOPED A CYST AND SURGEON EXPLANTED 6MM POLY TO ACCESS AND REMOVE CYST. SURGEON IMPLANTED NEW 6MM STAR POLY.
Patient problems: Cyst(s)
MAUDE report 12139246 ↗InjuryJun 11, 2021Fracture; Fracture
AS REPORTED: STAR POLY SWAP FOR A FRACTURED POLY.
Patient problems: Failure of Implant
MAUDE report 11984187 ↗InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WAS IN PAIN, WHICH RESULTED IN REVISION SURGERY.
Patient problems: Pain
MAUDE report 11728919 ↗InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT HAD PAIN DUE TO EXOSTOSIS FIBULA/LATERAL GUTTER IMPINGEMENT (SEEN ON X-RAY) AND HAD AN EXOSTECTOMY.
Patient problems: Implant Pain
MAUDE report 10788178 ↗InjuryOct 29, 2020Fracture; Fracture
AS REPORTED: "WHILE DOING A GUTTER DEBRIDEMENT OF THE PATIENT'S RIGHT ANKLE, THE STAR POLY WAS FOUND TO HAVE BEEN BROKEN AND WAS REVISED TO A STAR POLY OF THE SAME SIZE."
Patient problems: Failure of Implant
MAUDE report 10757153 ↗InjuryMay 21, 2020Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE PATIENT'S ANKLE WAS REVISED. SURGEON ORIGINALLY SUSPECTED THAT THE POLY WAS FRACTURED, BUT INTRA-OPERATIVELY, IT WAS NOTED THAT ONE OF THE WIRES HAD DETACHED FROM THE POLY AND WAS FLOATING LOOSE, AND THAT THERE WAS VISIBLE WEAR TO ONE CORNER OF THE POLY (NO FRACTURES).
Patient problems: Injury
MAUDE report 10080362 ↗InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT RECEIVED STAR IN THE RIGHT ANKLE ON (B)(6) 2017 FOR PRIMARY ARTHROSIS. PATIENT PRESENTED WITH PAIN, DESCRIBED AS SWELLING IN THE ANKLE ON (B)(6) 2017. THE INVESTIGATOR DEEMED THIS AE AS MODERATE AND POSSIBLY RELATED TO THE DEVICE. AT THE TIME OF THIS REPORT, THIS ADVERSE EVENT IS ONGOING AND CONTINUING WITHOUT TREATMENT.
Patient problems: Pain; Swelling
MAUDE report 9845494 ↗InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT ANKLE WAS REVISED DUE TO SUSPECTED INFECTION (UNKNOWN IF INFECTION CLINICALLY CONFIRMED, OR IF THE INFECTING MICROORGANISM WAS IDENTIFIED). AN IRRIGATION AND DEBRIDEMENT WITH A POLY SWAP OF THE SAME-SIZED POLY WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 9143468 ↗
Other Prosthesis, Ankle, Uncemented, Non-Constrained devices
- STAR 400-141FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained24 reports
- STAR 400-142FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained23 reports
- STAR 400-263Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR 400-144FStryker 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
- STAR™ 99-0028/11FStryker 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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