Vantage 350-12-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862276186), received between Feb 15, 2021 and Mar 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K152217); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 58 YEAR OLD FEMALE PATIENT HAD AN INITIAL TOTAL ANKLE ARTHROPLASTY ON (B)(6) 2022. THE PATIENT PRESENTED WITH A FAILED TIBIAL COMPONENT AND HAD IMMEDIATE PAIN, SWELLING, AND CYST FORMATION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE VANTAGE TOTAL ANKLE IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. CULTURES WERE TAKEN. NO INFECTION. CUSTOM CAGE IMPLANT BEING MADE FOR AN ANKLE FUSION. THE REPORTED EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Cyst(s); Failure of Implant; Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 16655283 ↗
• InjuryFeb 15, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1.5 YEARS POSTOP THE INITIAL RIGHT ANKLE IMPLANT, THIS FEMALE PATIENT EXPERIENCED TIBIAL LOOSENING AND WAS REVISED. PATIENT IS DOING WELL NOW. REMOVAL OF VANTAGE IMPLANT. NO OTHER INFORMATION AVAILABLE AS REVISION WAS COMPLETED OUT OF THE CLINICAL STUDY AND NO STUDY ID WAS AVAILABLE. DEVICE IS NOT RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 11330181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152217. One submission often covers many models, so check the product and lot details in each record.

• Z-0587-2024 · Nov 21, 2023 · Open, Classified
  Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
• Z-0024-2022 · Aug 30, 2021 · Open, Classified
  Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Co
• Z-2926-2020 · Aug 10, 2020 · Open, Classified
  The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
• Z-2966-2018 · Jul 13, 2018 · Terminated
  Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
• Z-0201-2018 · May 16, 2017 · Terminated
  Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degene
• Z-0200-2018 · May 16, 2017 · Terminated
  Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or dege