Vantage 350-11-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862276162), received between May 31, 2019 and Jan 27, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, INSTABILITY, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, SCAR TISSUE, FAILURE OF IMPLANT, JOINT LAXITY, AND IMPLANT PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Scar Tissue

  MAUDE report 21246188 ↗
• InjuryMar 28, 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, APPROXIMATELY 2.5 YEARS POST INITIAL LEFT TAA, THE 72 Y/O MALE PATIENT RETURNED FOR PAIN BELOW TAA. THE SURGEON DETERMINED THERE IS IRREGULARITY IN THE SUBTALAR JOINT. PATIENT WAS GIVEN INJECTION STEROID INTO SUBTALAR JOINT. THEN, ON (B)(6) 2023, FOLLOW-UP FROM HIS SINUS TARSI INJECTION ON THE LEFT ANKLE. THE PATIENT STATES THAT HE DID NOT GET ANY RELIEF EVEN TEMPORARILY WITH THE SHOT. THE PATIENT IS MOSTLY TENDER OVER THE POSTERIOR TIBIAL TENDON. REFERRAL TO ANOTHER SURGEON FOR CONSIDERATION OF OPENING DEBRIDEMENT AND FDL TENDON TRANSFER. ON (B)(6) 2023, THE PATIENT WAS THERE FOR FOLLOW-UP. PATIENT HAS TRIED PT/HEP. PAIN WORSENING. ISOLATED TO THE POSTEROMEDIAL ANKLE. HAS LEFT POSTERIOR TIBIAL TENDINITIS/PARTIAL TEARING IN THE SETTING OF PRIOR TAA. THE EVENT WAS RESOLVED WITH PATIENT HAVING A REVISION ON (B)(6) 2024. PER CLINICAL REPORT, THE REPORTED EVENT IS DEFINITELY NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Implant Pain; Pain

  MAUDE report 18990537 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 71 YO MALE PATIENT IS STILL EXPERIENCING DISCOMFORT IN LEFT ANKLE WITH SHARP ACHING PAIN ON THE ANTEROMEDIAL ASPECT OF ANKLE. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2021. THE PROVIDER PLANNED TO DO REVISION SURGERY TO REMOVE VANTAGE AND REPLACE WITH INBONE. THE PATIENT WAS REVISED ON (B)(6) 2021. THERE WAS A PREVIOUS SURGERY (DEBRIDEMENT) ON INVOLVED ANKLE (B)(6) 2014. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Discomfort; Pain

  MAUDE report 16561161 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 63 YO FEMALE PATIENT CONSISTENTLY HAD PAIN FROM THE TIME SINCE THE FIRST SURGERY. PATIENT CONTINUES TO HAVE PAIN IN DORSUM OF FOOT AND AN INABILITY TO AMBULATE WELL SECONDARY TO THE PAIN. THE DATE OF ONSET IS 06-09-2020. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16553183 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem

  INDEX SURGERY: (B)(6) 2019. SOMETIME DURING THE INITIAL 3 MONTH POST-OP PERIOD THE PATIENT DEVELOPED AN INFECTION IN HIS ANKLE. THE VANTAGE IMPLANT WAS REMOVED BY AN OUTSIDE SURGEON AT THE (B)(6) CLINIC IN (B)(6) (CLOSER TO PATIENT'S HOME) IN (B)(6) 2019. THE EXACT DATE IS UNKNOWN. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 8658896 ↗

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