STAR 400-254Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00886385016450), received between Feb 2, 2018 and May 26, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Slipped” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 7MM POLY FOR THE ANKLE WAS REVISED AND A 400-141 WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11887446 ↗
• 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 10781355 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD RIGHT ANKLE SURGERY DONE ON (B)(6) 2013. PATIENT STATED THAT APPROX IN 2016 SHE FELT AS IF SHE HAD BROKEN HER ANKLE AGAIN. PATIENT HAS BEEN EXPERIENCING STABBING PAIN, CANNOT PUT WEIGHT ON HER ANKLE, SWELLING, HER ALIGNMENT IS OFF BALANCE, SORENESS ON HER LOWER BACK, ANKLE FEELS HOT, INSTABILITY, NUMBNESS IN THE BACK OF HER HEEL AND SHE NOW HAS A CLICKING SOUND. PATIENT STATED THE PAIN WILL WAKE HER DURING THE NIGHT. PATIENT CANNOT WEAR SHOES DUE TO THE SWELLING. THE PATIENT STATED THAT THIS HAS AFFECTED HER KNEES AND HAS BEEN TOLD THAT SHE IS NOW A CANDIDATE FOR KNEE REPLACEMENT. PATIENT TAKES TRAMADOL FOR HER PAIN. PATIENT HAS HAD PHYSICAL THERAPY ON A YEARLY BASIS TO THE MAXIMUM ALLOWED BY HER INSURANCE.

  Patient problems: Implant Pain; Numbness; Swelling/ Edema

  MAUDE report 10564335 ↗
• 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 9845621 ↗
• InjuryJan 28, 2019Loose or Intermittent Connection

  TODAY AT ST. VINCENT HEALTHCARE WE HAD A CASE IN WHICH WE REVISED A PREVIOUS STAR TOTAL ANKLE ARTHROPLASTY. DR. WAS THE SURGEON AND TOLD ME BEFORE THE CASE STARTED THAT HE WOULD LIKE TO JUST PULL THE TALAR COMPONENT AND POLY INSERT AND THEN REPLACE BOTH OF THEM WITH LIKELY THE SAME SIZE, POSSIBLY A SIZE SMALLER. HE SAID THAT HE SUSPECTS THE TALAR COMPONENT TO BE LOOSE AFTER VIEWING IT BEFORE THE OPERATION IN X-RAY. THE TALAR COMPONENT WAS LOOSE AND HE PULLED IT OUT AND MADE A COMMENT ABOUT HOW HE SAW NO BONY IN-GROWTH ON THE IMPLANT. WE MADE A FEW ADJUSTMENTS AND PUT IN TWO NEW IMPLANTS AND THE CASE WENT FAIRLY SMOOTHLY, I JUST WANTED TO MAKE SURE TO REPORT HIS OBSERVATION THAT THERE WAS VIRTUALLY NO BONY IN-GROWTH ON THE TALAR COMPONENT HE REMOVED. THE ISSUE WAS NOTICED DURING THE OPERATION WHEN THE SURGEON REMOVED THE PREVIOUSLY IMPLANTED TALAR COMPONENT.

  Patient problems: No Code Available

  MAUDE report 8283518 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN CLINICAL INVESTIGATION, ON (B)(4) 2017 AN 11MM OSTEOLYSIS WAS SEEN ON SUBJECT CT SCAN ON THE RIGHT SIDE LOCATED NEAR THE MEDIAL BARREL AND MEDIAL MALLEOLAR. ADVERSE EVENT ONSET WAS ABOUT 11 MONTHS POST-OP OF A STAR IN HER RIGHT ANKLE OF (B)(6) 2017. SUBJECT IS UNDERGOING OBSERVATION AND EVENT IS ONGOING WITHOUT TREATMENT.

  Patient problems: Osteolysis

  MAUDE report 7379611 ↗
• InjuryFeb 2, 2018Device Slipped; Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE FOLLOWING EVENT WAS REPORTED BY PATIENT¿S WIFE: MY HUSBAND RECEIVED A STAR ANKLE REPLACEMENT ON (B)(6) 2012. AT FIRST EVERYTHING SEEMED TO BE GOING WELL UNTIL (B)(6) 2016, WHEN HE STARTED HAVING PAIN IN ANKLE. MADE AN APPOINTMENT WITH DOCTOR WHO PERFORMED THE SURGERY AND AFTER READING X-RAYS HE THOUGHT THE APPARATUS SHIFTED AND HE MIGHT HAVE TO REPLACE A PART. TOLD HIM TO WEAR A BOOT AND KEEP WEIGHT OFF OF ANKLE AND COME BACK IN SIX WEEKS. AFTER SIX WEEKS NO IMPROVEMENT DOCTOR THOUGHT MAYBE BONE UNDER APPARATUS WAS COLLAPSING AND HE MIGHT HAVE TO SCRAPE BONE TO BUILD BACK UP. AGAIN 6 WEEKS WITH BOOT AND THEN RETURN TO SEE HIM. DURING THAT SIX WEEK INTERVAL HE FRACTURED HIS TIBIA. AT THIS APPOINTMENT HE MENTIONED THAT POSSIBLY IT WAS AVASCULAR NECROSIS AND NOTHING COULD BE DONE EXCEPT TAKING OUT APPARATUS AND FUSING THE ANKLE. MY HUSBAND TOLD HIM HE DID NOT WANT TO DO A FUSION. DOCTOR POINTED OUT WE WERE IN "UNCHARTERED TERRITORY", AS HE HAD NEVER HAD A PATIENT EXPERIENCE THIS PROBLEM. AGAIN 6 WEEKS BOOT AND NO WEIGHT. AT NEXT APPOINTMENT DOCTOR SAID FRACTURE HEALED AND THE COLLAPSED BONE SEEMED TO BE REGENERATING ITSELF AND HE SAID TO RESCHEDULE AN APPOINTMENT FOR 6 MONTHS (WHI

  Patient problems: Bone Fracture(s); Failure of Implant; Fall; Implant Pain; Inadequate Osseointegration; Necrosis; Pain

  MAUDE report 7238544 ↗