STAR 400-142FRecalls & reported problems
Stryker GmbH · Sliding Core, UHMPWE, 8mm · Class 3 · Implant
Quick summary
This Stryker STAR total ankle replacement sliding core (a plastic insert used in ankle implants) has 23 adverse event reports, all involving injuries and no deaths. Reports mostly describe revision surgeries, citing wear of the plastic component, instability, loosening, and pain. No recalls name this device. Report filings rose from 1 in the prior 12 months to 7 in the most recent 12 months.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00886385026947), received between Mar 28, 2018 and Apr 20, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Unstable” (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. 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 Problem13
- Unstable3
- Device Dislodged or Dislocated2
- Loss of Osseointegration2
- Fracture1
- Inadequacy of Device Shape and/or Size1
- Material Integrity Problem1
Patient problems
- Insufficient Information8
- Failure of Implant5
- Joint Laxity5
- Ankylosis1
- Deformity/ Disfigurement1
- Implant Pain1
- Loss of Range of Motion1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Unstable
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24678169 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24671387 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24671386 ↗InjuryMar 23, 2026Unstable
InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - "SIST FORMED ABOVE TIBIAL TRAY, DR. FILLED SIST WITH PRODENSE AND REPLACED STAR POLY." UNKNOWN REASON FOR POLY SWAP.
Patient problems: Insufficient Information
MAUDE report 24646423 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INDEPENDENT SALES REPRESENTATIVE SUBMITTED AN EMAIL WITH A REVISION SURGERY CASE SHEET FOR A 400-142F (SLIDING CORE STAR TOTAL ANKLE) UNKNOW REASON FOR THE REVISION.
Patient problems: Insufficient Information
MAUDE report 24634986 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN & LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 21905964 ↗InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, ENOVIS CUSTOMER CARE RECEIVED A DELIVERED GOODS FORM (DGF) FOR A STAR TOTAL ANKLE REVISION CASE, ALLEGEDLY DUE TO WEARING OF THE POLY DUE TO THE PATIENT DISLOCATING THEIR ANKLE SEVERAL YEARS AGO SECONDARY TO RHEUMATOID ARTHRITIS.
Patient problems: Failure of Implant
MAUDE report 18460602 ↗InjuryJun 28, 2023Material Integrity Problem; Material Integrity Problem
THE INITIAL POLYETHYLENE COMPONENT EXPERIENCED STRUCTURAL FAILURE, LEADING TO THE NEED FOR A REVISION PROCEDURE. THE ORIGINAL IMPLANT EMPLOYED WAS A 400-142F, SLIDING CORE, ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMPWE) MATERIAL, WITH A DIAMETER OF 8MM, AND HAD BEEN SURGICALLY PLACED IN 2021.
Patient problems: Failure of Implant
MAUDE report 17218645 ↗InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A POLY SWAP TOOK PLACE ON (B)(6) 2022 DUE TO AN INCISIONAL BREAKDOWN AND SOFT TISSUE DEHISCENCE. THE SURGEON REPORTED THAT THERE WAS NO FAILURE OF THE DEVICE. THE SURGEON DECIDED TO REMOVE THE 8MM POLY (400-142F LOT : 2127040) AND REPLACED IT WITH AN 7MM ( 400-141F LOT : 2013257) POLY INSTEAD DUE A CLEAN UP OF AN INDEPENDENT INFECTION CAUSING A SMALLER SPACE AT THE SURGICAL SITE.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 15875511 ↗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 13638955 ↗InjurySep 13, 2021Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THE IMPLANT WAS UNSTABLE, REQUIRING REVISION FOR A THICKER POLY.
Patient problems: Failure of Implant
MAUDE report 12459361 ↗InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IT HAD BEEN 10 YEARS SINCE THE POLY WAS REPLACED, SO IT WAS SWAPPED.
Patient problems: Insufficient Information
MAUDE report 12377600 ↗InjuryAug 13, 2021Fracture; Fracture
IT WAS REPORTED THE POLY BROKE, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 12318622 ↗InjuryJul 19, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THE PATIENT WAS UNSTABLE AND NEEDED A THICKER POLY FOR STABILITY. REVISION SURGERY WAS PERFORMED.
Patient problems: Joint Laxity
MAUDE report 12188930 ↗InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "THE CASE WAS SCHEDULED AS RT TOTAL ANKLE REVISION VS POLY EXCHANGE, POSSIBLE DELTOID RECONSTRUCTION, POSSIBLE 1ST TARSOMETATARSAL ARTHRODESIS. THE PATIENT PRESENTED WITH AN ANKLE IN VARUS. PATIENT WAS APPROXIMATELY FIVE YEARS POST PRIMARY TOTAL ANKLE. ONCE THE ANKLE WAS OPENED AND INSPECTED, THE SURGEON DECIDED THAT THE GUTTERS NEEDED CLEANING, THE DELTOID LIGAMENT WAS RELEASED AND THE POLY WAS EXCHANGED."
Patient problems: Deformity/ Disfigurement
MAUDE report 12131754 ↗InjuryJun 9, 2021Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THE PATIENT HAD UNSTABLE STAR TOTAL ANKLE. DR. STEVEN HAS ASSESSED THE PATIENT AND CHOSE A REVISION POLY EXCHANGE TO INCREASE SOFT TISSUE TENSION TO INCREASE STABILITY.
Patient problems: Joint Laxity
MAUDE report 11966704 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "REVISED DUE TO ANKYLOSIS. COMPONENT REMOVED TO ACCESS POSTERIOR PORTION OF THE JOINT. PATIENT EXPERIENCES LACK OF RANGE OF MOTION".
Patient problems: Ankylosis; Loss of Range of Motion
MAUDE report 11734816 ↗InjuryApr 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE FOLLOWING WAS REPORTED: PATIENT DISLOCATED STAR ANKLE REVISION; A SIZE 8 POLY WAS REMOVED AND REPLACED WITH A SIZE 9 POLY.
Patient problems: Failure of Implant
MAUDE report 11728962 ↗InjuryApr 9, 2021Unstable; Unstable
THE FOLLOWING EVENT WAS REPORTED:" PATIENT PRESENTED AT DR. M. OFFICE WITH ANKLE INSTABILITY. HE EXAMINED THE JOINT AND DETERMINED THAT A NEW POLY WAS NECESSARY. WE PERFORMED THE REVISION SURGERY AND SWAPPED THE 8MM POLY FOR A 9MM POLY. ORIGINAL DOS (B)(6) 2020.
Patient problems: Insufficient Information
MAUDE report 11645428 ↗InjuryMar 28, 2018Device Dislodged or Dislocated
PATIENT PRESENTED WITH PAIN AND SWELLING. ON X-RAY THE MOBILE BEARING WAS DISPLACED.
Patient problems: Pain; Swelling
MAUDE report 7379608 ↗
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 400-263Stryker 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.