STAR 400-264Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886385016559), received between Aug 8, 2017 and Jul 8, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2021Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PATIENT CALLED STATING HE HAD AN ANKLE SURGERY AROUND (B)(6), 2012. HE STATED ABOUT A MONTH AGO (DECEMBER 2018) HE STARTED EXPERIENCING DIFFICULTY WALKING. PATIENT ALSO STATED HE HAD X-RAYS DONE WHICH SHOW LOOSENING AND A GAP IN BETWEEN THE IMPLANT AND THE BONE. THE PATIENT WAS REVISED ON (B)(6) 2019, WHERE IT WAS FOUND THE STAR POLY COMPONENT WAS BROKEN IN HALF, SIGNIFICANT ANKLE SYNOVITIS.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain; Synovitis

  MAUDE report 12137513 ↗
• InjuryNov 3, 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 10780894 ↗
• MalfunctionMay 20, 2019Therapeutic or Diagnostic Output Failure

  SUBJECT RECEIVED A STAR IN THE RIGHT ANKLE ON (B)(6)2017. ON (B)(6)2019, SUBJECT SHOWS SLIGHT LUCENCY ABOVE LATERAL BARREL ON TIBIA. NO ACTION HAS BEEN TAKEN; THE SUBJECT IS CONTINUING WITHOUT TREATMENT. THIS EVENT DOES NOT INVOLVE DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625521 ↗
• InjuryApr 22, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT, DURING A STAR TOTAL ANKLE REVISION TO DO A POLY COMPONENT SWAP, ONCE EXPOSURE WAS MADE, THE TIBIAL COMPONENT WAS BROKEN. TIBIAL COMPONENT WAS REPLACED AND POLY WAS EXCHANGED. BECAUSE THE TIBIAL COMPONENT WAS BROKEN, THE CASE TIME WAS INCREASED TO REPLACE COMPONENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8537094 ↗
• InjuryAug 8, 2017Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2014 THE PATIENT UNDERWENT A TOTAL LEFT ANKLE REPLACEMENT SURGERY. IT IS ALLEGED THAT ON (B)(6) 2015 HE TWISTED HIS LEFT ANKLE AND ON (B)(6) 2016 THE IMPLANT CAUSED INJURY TO THE PATIENT DUE TO " HARDWARE FAILURE INVOLVING THE MEDIAL ASPECT OF THE ANKLE JOINT, FAILED TIBIAL COMPONENT RESULTING IN FAILED HARDWARE WITH MEDIAL MALLEOL OR NON UNION REQUIRING A REVISION AND REMOVAL OF SAID PRODUCT."

  Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

  MAUDE report 6775630 ↗