Vantage 350-11-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862276131), received between Jan 19, 2022 and Feb 2, 2026 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL ANKLE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND LOOSENING OF THE TIBIAL PLATE. AS A RESULT, THE PATIENT UNDERWENT AN ANKLE REVISION APPROXIMATELY 2 YEARS AND 9 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24234962 ↗
• InjuryJul 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT INQUIRED ABOUT A 3D PRODUCTS ABILITY TO BE USED FOR REVISION. THEY WERE LOOKING FOR ANY DATA CONCERNING USING THIS NEW PRODUCT AS A REVISION, WHERE IT WAS ATTEMPTED, AND WHO THE SURGEON WAS WHO DID IT. IT WAS INDICATED THE PATIENT HAD A STANDARD ANKLE IMPLANTED A YEAR PRIOR AND IT HAD COME LOOSE. NO FURTHER INFORMATION.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 22638110 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, THE 62 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TAA ON (B)(6) 2022 AND PRESENTED WITH LUCENCY AND CYST FORMATION APPROXIMATELY 1 YEAR POST INITIAL PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT'S RADIOGRAPHIC FINDINGS DETERMINED THERE IS INCREASED LUCENCY ABOUT THE TIBIAL COMPONENT COMPARED TO (B)(6) 2023. SUBJECT CAME IN FOR A FOLLOW-UP VISIT PERTAINING TO THE FINDINGS ON (B)(6) 2024. ON (B)(6) 2024, RADIOGRAPHIC FINDINGS STATED THAT THERE WAS STABLE LUCENCY ABOUT THE TIBIAL COMPONENT COMPARED TO (B)(6) 2023, BUT INCREASED SINCE (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THE ACTION TAKEN WAS MEDICATION AND THE OUTCOME OF THIS EVENT IS CONTINUING. 350-11-01 - TIBIAL PLATE FB SZ 1 LT: 6694220. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

  Patient problems: Cyst(s); Osteolysis

  MAUDE report 18620233 ↗
• InjuryJan 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING IMPACTION OF THE LEFT ANKLE, THE SURGEON WAS TRYING TO FURTHER SEAT THE TIBIAL JUST A BIT MORE AFTER ALREADY IMPACTING IT SEVERAL TIMES AND A SMALL PART OF THE RIM OF THE IMPLANT WHERE THE POLY INSERTS INTO BROKE OFF. THIS PREVENTED A TRIAL POLY FROM BEING PLACED IN THE COMPONENT AND ULTIMATELY THE SURGEON TOOK THAT TIBIAL TRAY OUT AND PUT A NEW ONE IN ITS PLACE. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION OR MEDICAL HISTORY WAS REPORTED. DEVICES WILL BE RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 13290666 ↗

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 Line
• 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-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
• 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