STAR 400-141FRecalls & reported problems
Stryker GmbH · Sliding Core, UHMPWE, 7mm · Class 3 · Implant
All models of STAR (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Stryker STAR ankle replacement insert (the plastic sliding core component). There are 24 adverse event reports naming this identifier, all injuries with no deaths, mostly describing patients needing revision surgery to replace the polyethylene insert, sometimes due to infection, pain, or poor range of motion. No recalls name this device. Reports picked up recently, with 6 in the past 12 months versus none in the 12 months before.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00886385026930), received between Apr 5, 2019 and Apr 3, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Fracture” (6 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 Problem16
- Fracture6
- Break3
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
- Naturally Worn1
Patient problems
- Failure of Implant7
- Insufficient Information7
- Implant Pain4
- Loss of Range of Motion2
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Pain1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24780720 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24772721 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - . POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24646420 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SURGEON PERFORMED A "GUTTER DEBRIDEMENT AND POLY SWAP. HOSPITAL JUST NOTIFIED REP THAT PROCEDURE WAS DONE. NO ISSUES."UNKNOWN REASON FOR POLY SWAP.
Patient problems: Insufficient Information
MAUDE report 24646416 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POOR RANGE OF MOTION.
Patient problems: Loss of Range of Motion
MAUDE report 19717059 ↗InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 10/03/2023, CUSTOMER CARE REPRESENTATIVE, EMAILED A DELIVERED GOODS FORM FOR A STAR TOTAL ANKLE REVISION SURGERY TO FA COMPLAINTS INBOX. THE STAR TOTAL ANKLE REVISION CASE WAS A POLY SWAP (400-141F, SLIDING CORE UHMPWE, 7MM) WHICH WAS DONE AT (B)(6) HOSPITAL BY DR. (B)(6) ON A 76 YEAR OLD FEMALE PATIENT. REGIONAL ACCOUNT COORDINATOR, EMAILED INDEPENDENT SALES REPRESENTATIVE, WHO WAS PRESENT AT THE CASE FOR DETAILS REGARDING THE POLY SWAP. SAGE STATED THAT THE ORIGINAL IMPLANT OF THE 400-141F WAS DONE ABOUT 7 YEARS AGO. DR. SAW THE PATIENT BACK FOR TAA FOLLOW UP AND THE 400-141F "APPEARED TO BE BROKEN ON X-RAY DUE TO METAL WIRE BEING SPLIT IN HALF. WIRE DISENGAGED FROM THE POLY, WAS BROKEN, BUT THE SLIDING CORE APPEARED TO BE INTACT WITH MINIMAL WEAR". THE EXPLANTED 400-141 WAS DISCARDED BY THE FACILITY HOWEVER, SAGE PROVIDED A PICTURE OF THE 400-141F.
Patient problems: Failure of Implant
MAUDE report 18655379 ↗InjuryNov 28, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A REVISION TOOK PLACE. THE EXPLANTED "POLY WAS BROKEN" AND THE "POLY WAS THROWN AWAY" AFTER REMOVAL. A NEW POLY WAS IMPLANTED AFTER THE BROKEN POLY WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 15874814 ↗InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT NEEDED MEDIAL GUTTER CLEAN OUT FOLLOWING TAA. AFTER SURGEON REMOVED BONE FROM THE MEDIAL GUTTER, POLY BEARING WAS SWAPPED WITH NEW POLY."
Patient problems: Insufficient Information
MAUDE report 15851579 ↗InjuryAug 29, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A POLY SWAP TOOK PLACE ON (B)(6) 2022 DUE TO THE POLY BREAKING. THE ORIGINAL POLY WAS IMPLANTED IN 2014.
Patient problems: Failure of Implant
MAUDE report 15312490 ↗InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT RECEIVED A STAR TOTAL ANKLE APPROXIMATELY 10 YEARS AGO. PATIENT STARTED EXPERIENCING MEDICAL PAIN AND WAS BROUGHT IN FOR A POLY EXCHANGE AND GUTTER CLEAN OUT . STAR POLY WAS REMOVED BY THE SURGEON. SURGEON EXAMINED THE POLY AND DETERMINED THAT IT WAS A 7MM POLY AND TRIALED AND REPLACED WITH A NEW 7MM POLY".
Patient problems: Implant Pain
MAUDE report 14584682 ↗InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT HAD MILD DISCOMFORT, DUE TO LOOSE OSSEOUS BODY IN THE JOINT".
Patient problems: Implant Pain
MAUDE report 13999303 ↗InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY SWAP REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13638936 ↗InjuryDec 6, 2021Naturally Worn; Naturally Worn
THE CUSTOMER REPORTED THE FOLLOWING EVENT: "PATIENT LOST RANGE OF MOTION IN ANKLE. REPLACED BEARING PN 400-141F WITH BEARING PN 400-1410F. REVISION WAS DUE TO POLY WEAR."
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 12934913 ↗InjuryNov 16, 2021Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
THE PATIENT REPORTED VIA MEDWATCH MW5103767 "I HAD A TOTAL ANKLE JOINT REPLACEMENT SURGERY DONE ON MY LEFT ANKLE DUE TO RHEUMATOID ARTHRITIS IN 2020 I HAVE HAD NOTHING BUT ISSUES AND WILL HAVE TO HAVE A REVISION DONE IN THE NEXT MONTH AS THE IMPLANT IS TOO LARGE FOR MY ANKLE AND CAUSES ONGOING PAIN AND SWELLING" IT WAS FURTHER CLARIFIED IN A PHONE CALL ON(B)(6)2021 WITH THE PATIENT THAT THEY HAD A TOTAL ANKLE JOINT REPLACEMENT SURGERY DONE ON MY LEFT ANKLE DUE TO RHEUMATOID ARTHRITIS ON (B)(6) 2020. IN(B)(6) OF 2020 PATIENT STARTED NOTICING ISSUES. PATIENT DID NOT SEE ANY IMPROVEMENTS. ANKLE WAS SWOLLEN AND REMAINED PAINFUL. SURGEON HAD TOLD THE PATIENT IT TAKES A YEAR TO HEAL BUT DID NOT NOTICE ANY PROGRESS AFTER THE SURGERY. PATIENT HAD DONE HER OWN RESEARCH AND FEELS THE IMPLANT IS TOO BIG AND IS DIGGING INTO HER BONE MORE THAN IT SHOULD. THE SURGEON CONFIRMED THAT THE IMPLANT IS DIGGING INTO THE PATIENT'S BONE AND IS NOT QUITE RIGHT. THE PATIENT GOT A CORTISONE SHOT AND IT DID NOT HELP. THE SURGEON SAID HE WAS NOT SURE IF HE PUT IN A SMALL OR X-SMALL IMPLANT IN THE PATIENT'S FOOT. LATER CLAIMED HE PUT IN AN X-SMALL. A CT-SCAN WAS CONDUCTED AND WAS SENT TO ANOTHER COMPANY. THE S
Patient problems: Implant Pain; Swelling/ Edema
MAUDE report 12818766 ↗InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: THE PATIENT PRESENTED WITH A STIFF ANKLE ON THE MEDIAL SIDE AND A GUTTER DEBRIDEMENT WAS DETERMINED AS THE PROCEDURE. DOCTOR ALSO DETERMINED THAT A POLY EXCHANGE WOULD BE NICE SINCE THE ANKLE WAS OPENED. DECISION WAS MADE AT TIME OF SURGERY. PATIENT'S PRIMARY ANKLE WAS DONE APPROXIMATELY SEVEN YEARS GO.
Patient problems: Insufficient Information
MAUDE report 12127570 ↗InjuryJul 6, 2021Fracture; Fracture
THE PATIENT BROKE THE POLY JUMPING FROM THE BACK OF A TRUCK, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12124810 ↗InjuryJun 17, 2021Fracture; Fracture
IT WAS REPORTED THE PATIENT FELL AND CRACKED THE POLY. REVISION SURGERY WAS REQUIRED.
Patient problems: Failure of Implant
MAUDE report 12016884 ↗InjuryJun 9, 2021Fracture; Fracture
IT WAS REPORTED THE POLY BROKE IN HALF. IT WAS REPLACED WITH A NEW POLY.
Patient problems: Failure of Implant
MAUDE report 11966726 ↗InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: SURGEON REPLACED POLY WITH A THICKER POLY. SURGERY WAS SCHEDULED FOR A PAINFUL H/W REMOVAL (4.0 HEADED SCREW) IN THE MEDICAL MALLEOLUS. HE DECIDED TO REPLACE THE POLY WHILE DOING THE H/W REMOVAL.
Patient problems: Insufficient Information
MAUDE report 11750642 ↗InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED PAIN IN THE ANKLE, RESULTING IN REVISION SURGERY.
Patient problems: Pain
MAUDE report 11728849 ↗InjuryApr 5, 2019Break; Fracture; Appropriate Device Problem Term/Code Not Available; Fracture
SLIDING CORE BROKE AFTER 6 YEARS. AFTER REVISION, DEBRIDEMENT AND IMPLANTATION OF A NEW SLIDING CORE WERE PERFORMED.
Patient problems: No Information
MAUDE report 8487670 ↗
Other Prosthesis, Ankle, Uncemented, Non-Constrained devices
- STAR 400-140FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained27 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
- 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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