STAR 400-262Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886385016535), received between Mar 16, 2020 and Nov 16, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2021Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE PATIENT REPORTED VIA MEDWATCH MW5103767 "I HAD A TOTAL ANKLE JOINT REPLACEMENT SURGERY DONE ON MY LEFT ANKLE DUE TO RHEUMATOID ARTHRITIS IN 2020 I HAVE HAD NOTHING BUT ISSUES AND WILL HAVE TO HAVE A REVISION DONE IN THE NEXT MONTH AS THE IMPLANT IS TOO LARGE FOR MY ANKLE AND CAUSES ONGOING PAIN AND SWELLING" IT WAS FURTHER CLARIFIED IN A PHONE CALL ON (B)(6)2021 WITH THE PATIENT THAT THEY HAD A TOTAL ANKLE JOINT REPLACEMENT SURGERY DONE ON MY LEFT ANKLE DUE TO RHEUMATOID ARTHRITIS ON (B)(6)4TH 2020. IN (B)(6) OF 2020 PATIENT STARTED NOTICING ISSUES. PATIENT DID NOT SEE ANY IMPROVEMENTS. ANKLE WAS SWOLLEN AND REMAINED PAINFUL. SURGEON HAD TOLD THE PATIENT IT TAKES A YEAR TO HEAL BUT DID NOT NOTICE ANY PROGRESS AFTER THE SURGERY. PATIENT HAD DONE HER OWN RESEARCH AND FEELS THE IMPLANT IS TOO BIG AND IS DIGGING INTO HER BONE MORE THAN IT SHOULD. THE SURGEON CONFIRMED THAT THE IMPLANT IS DIGGING INTO THE PATIENT'S BONE AND IS NOT QUITE RIGHT. THE PATIENT GOT A CORTISONE SHOT AND IT DID NOT HELP. THE SURGEON SAID HE WAS NOT SURE IF HE PUT IN A SMALL OR X-SMALL IMPLANT IN THE PATIENT'S FOOT. LATER CLAIMED HE PUT IN AN X-SMALL. A CT-SCAN WAS CONDUCTED AND WAS SENT TO ANOTHER COMPANY.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 12818542 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED." PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON (B)(6), 2021 THE EVENT IS AS FOLLOW: (B)(6) 2015 : ANTERIOR ANKLE ARTHROTOMY WITH REMOVAL OF TOTAL ANKLE IMPLANT WITH BONE CULTURE AND BIOPSY. ¿ 5TH INTERVENTION

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 11689416 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED." PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON (B)(6) 2021 THE EVENT IS AS FOLLOW: DENERVATION OF SUPERFICIAL PERONEAL NERVE, RIGHT ANKLE ¿ 4TH INTERVENTION.

  Patient problems: Neuralgia

  MAUDE report 11689398 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED." PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON MARCH 25TH, 2021. THE EVENT IS AS FOLLOW: (B)(6) 2015 : LATERAL ANKLE ARTHROTOMY WITH BONE CULTURES AND IRRIGATION OF RIGHT ANKLE - 2ND INTERVENTION.

  Patient problems: Unspecified Infection

  MAUDE report 11679287 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ANKLE PAIN. EXPLANTATION OF STAR TOTAL ANKLE AND REVISION TO TTC."

  Patient problems: Implant Pain

  MAUDE report 10805481 ↗
• 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 [04FEB2020] DUE TO DEVICE FAILURE. AE ONSET DATE WAS 12DEC2019. 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 9838176 ↗