STAR 400-144FRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886385026961), received between Sep 21, 2015 and Apr 20, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 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 24933083 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24761074 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, INDEPENDENT SALES REPRESENTATIVE, EMAILED FA INVENTORY REQUESTING A STAR TRAY AND IMPLANT BANK FOR A STAR TOTAL ANKLE POLY EXCHANGE CASE ON (B)(6) 2024 AT MERCYONE WEST LAKES HOSPITAL ON A 66 YEAR OLD MALE PATIENT (DOB:(B)(6) 1957). REGIONAL ACCOUNT COORDINATOR, FOLLOWED UP WITH INDEPENDENT SALES REPRESENTATIVE, REGARDING CASE DETAILS. SHE STATED THE PATIENT "HAS HAD STAR FOR 11 YEARS AND 2 POLYS (400-144F, SLIDING CORE, UHMPWE, 10MM) HAVE BROKE WITHIN 11 YEARS". INDEPENDENT SALES REPRESENTATIVE REPORTED THAT THE PATIENT WAS COMPLIANT HOWEVER HAS COMORBIDITIES INCLUDING DVT, ED, GERD, AND HYPERTENSION. IT IS UNKNOWN WHEN THE 1ST 400-144F BROKE.

  Patient problems: Failure of Implant

  MAUDE report 18708165 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF A STAR SLIDING CORE TOTAL ANKLE IMPLANT. THE PATIENT CAME IN REPORTING PAIN AT TIBIAL SITE. THE SURGEON NOTICED THAT THERE WAS A CYST FORMING AT THE TOP OF THE TIBIA AND DECIDE TO REMOVE THE CYST AND THE 10MM POLY. DUE TO REMOVAL THE SURGEON REPLACED THE SITE WITH AN 11MM POLY, BECAUSE THERE WAS SPACE AFTER THEY CUT THE CYST OUT. THE SURGEON DID NOT REPORT THAT THE POLY CAUSED THIS AND THE ORIGINAL POLY WAS INTACT

  Patient problems: Cyst(s); Implant Pain

  MAUDE report 15840763 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS: "PATIENT REQUIRED ANKLE FUSION AND DOCTOR REQUESTED POLY-EXCHANGE"

  Patient problems: Insufficient Information

  MAUDE report 13776697 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN REVISED THE POLY IN THE PATIENT DURING A DIFFERENT SURGERY. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690804 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT STATES A "POLY SWAP". REVISION SURGERY PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569455 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13198903 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD IMPINGEMENT FOLLOWING PRIOR TAA. SURGEON DETERMINED THAT MEDIAL GUTTER NEEDED TO BE DEBRIDED. WHILE PERFORMING THE DEBRIDEMENT, SURGEON DECIDED TO PERFORM A POLY SWAP. NO EXCESSIVE WEAR WAS FOUND ON EXPLANTED POLY."

  Patient problems: Inadequate Pain Relief

  MAUDE report 12795141 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT RECEIVED STAR IN THE LEFT ANKLE ON (B)(6) 2018 FOR PRIMARY ARTHROSIS, WITH LEFT GASTROCSOLEUS RECESSION, LEFT DISTAL TIB/FIB FUSION, LEFT PLACEMENT OF MEDIAL MALEOLAR SCREWS FOR PROPHYLAXIS FOR IMPENDING MEDIAL MALLEOLAR FRACTURE, AND A SEPARATE INCISION FOR LEFT SECONDARY LATERAL LIGAMENT RECONSTRUCTION. SUBJECT WAS CONTACTED FOR FOLLOW-UP AND STATED THAT SHE HAD HER LEFT ANKLE REPLACEMENT REMOVED ON [ (B)(6) 2020] DUE TO DEVICE FAILURE. AE ONSET DATE WAS ON (B)(6) 2019. THE INVESTIGATOR DEEMED THIS AE AS SEVERE WITH UNKNOWN RELATIONSHIP TO THE DEVICE AT THE TIME OF THIS REPORTING. AS OF THE TIME OF THIS REPORT, THIS ADVERSE EVENT IS RECOVERED WITH TREATMENT (SURGERY: REVISION/REMOVAL OF STAR)."

  Patient problems: Failure of Implant; Injury

  MAUDE report 9838240 ↗
• InjurySep 21, 2015Fracture

  PATIENT HAS HAD MULTIPLE SURGERIES. ANKLE FELL BACK INTO VARUS. POLY WAS FOUND TO BE FRACTURED. ACHILLES LENGTHENING, DELTOID RELEASE, MEDIAL RELEASE ( A LOT OF SCARRING) WEAK POSTERIOR TENDON TIGHTENED UP.

  Patient problems: No Code Available

  MAUDE report 5092136 ↗