STAR 400-263Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886385016542), received between Feb 2, 2018 and Nov 14, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20691763 ↗
• InjuryOct 20, 2021Fracture; Fracture

  A PATIENT REPORTED VIA MEDWATCH MW5102110 THAT THEY HAD A STAR ANKLE REPLACEMENT IN 2013. PAIN HAD STEADILY INCREASED OVER THE LAST SIX MONTHS. THE DOCTOR HAD TO PERFORM A POLYETHYLENE REPLACEMENT (B)(6) 2021. THE ORIGINAL INSERT WAS POTENTIALLY BROKEN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12668701 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT HAD OSTEOPHYTES WHICH CAUSED MEDIAL IMPINGEMENT. SUBJECT HAD OSTEOPHYTES REMOVED ON (B)(6) 2018 IN WHICH THE AE RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10892012 ↗
• 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 10564334 ↗
• 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 9845493 ↗
• InjuryMay 3, 2019Device Slipped

  IT WAS REPORTED FROM THE CLINICAL TEAM THAT THE SUBJECT RECEIVED A STAR IN THE LEFT ANKLE ON(B)(6)2017. ON(B)(6)2018, SUBJECT PRESENTED WITH LEFT TALAR SUBSIDENCE WITH SUBTALAR CYSTIC CHANGE RESULTING IN DEVICE SUBSIDENCE. THE CLINICAL INVESTIGATOR DEEMS THIS AE AS SEVERE AND RELATED TO THE DEVICE. THE SUBJECT IS EXPECTED TO RECEIVE SURGICAL INTERVENTION FOR HER LEFT ANKLE IN THE COMING MONTHS.

  Patient problems: No Code Available

  MAUDE report 8579885 ↗
• InjuryMay 3, 2019Migration

  SUBJECT RECEIVED A STAR IN THE LEFT ANKLE ON (B)(6) 2017. ON (B)(6) 2018, SUBJECT PRESENTED WITH LEFT TALAR SUBSIDENCE WITH SUBTALAR CYSTIC CHANGE RESULTING IN DEVICE MIGRATION. THE INVESTIGATOR DEEMS THIS AE AS SEVERE AND RELATED TO THE DEVICE. THE SUBJECT IS EXPECTED TO RECEIVE SURGICAL INTERVENTION FOR HER LEFT ANKLE IN THE COMING MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 8579745 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA AN ADVERSE EVENT REPORT ((B)(6) STUDY) THAT THE SUBJECT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018, SEVEN DAYS POST-OP OF A STAR IN LEFT ANKLE ON (B)(6) 2018. THE SUBJECT WAS DIAGNOSED WITH BILATERAL SECOND AND THIRD ORDER PULMONARY EMBOLI. ULTRASOUND OF RIGHT LEG SHOWED AN INFRAPOPLITEAL TIBIAL VEIN THROMBUS. NO THROMBI ABOVE THE KNEE FOUND IN EITHER LEG. THE LEFT LOWER LEG COULD NOT BE SOUNDED BECAUSE OF WOUND DRESSING. SUBJECT WAS PRESCRIBED WITH AN ANTICOAGULATION OF ELIQUIS 10 MG. PATIENT WAS DISCHARGED ON (B)(6) 2018 AND EVENT IS CONTINUING WITH TREATMENT".

  Patient problems: Pulmonary Embolism; Thrombosis

  MAUDE report 7593457 ↗
• InjuryMar 28, 2018Insufficient Device Problem Information

  TIBIAL REVISION AND POLY EXCHANGE

  Patient problems: No Code Available

  MAUDE report 7379612 ↗
• 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)(6) 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 7379609 ↗
• InjuryFeb 2, 2018Break; 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) OF 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 (

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fall; Implant Pain; Inadequate Osseointegration; Pain

  MAUDE report 7238550 ↗