Vantage 350-12-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862276193), received between May 31, 2019 and Mar 20, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Implant subsidence; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Implant subsidence

  AS REPORTED BY THE EXACTECH VANTAGE TOTAL ANKLE STUDY, THE 33-YEAR-OLD FEMALE PATIENT HAD A RIGHT TAA ON (B)(6) 2018. ON (B)(6) 2022, THE PATIENT PRESENTED WITH PAIN STATING SHE NOTICED SOME DISCOMFORT DURING THE PREVIOUS WINTERTIME. SHE STATED HER ANKLE IS DOING WELL WITH MINIMUM PAIN AND ASYMPTOMATIC MOST DAYS. ON (B)(6) 2023, DR. (B)(6) ORDERED CT SCAN BECAUSE SHE HAD COMPLAINTS LATERALLY AND HER X-RAYS SHOWED SOME GROWTH OF THE CYST IN THAT AREA. ON (B)(6) 2023, DR. (B)(6) STATED THAT THE SUBJECT DESCRIBED HER PAIN AS ACHING AND BURNING, MORE INTENSE WITH ACTIVITY. THE SYMPTOMS ARE AGGRAVATED BY STANDING, WALKING, AND WEIGHT BEARING. DR. (B)(6) ELECTED TO PROCEED WITH REVISION. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED BY ACTION OF REVISION ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Cyst(s); Discomfort; Pain

  MAUDE report 18941304 ↗
• InjuryMar 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 78 YO MALE PATIENT HAD X-RAYS THAT SHOWED A PROGRESSION OF TIBIAL COMPONENT SUBSIDENCE INTO THE ANTERIOR TIBIA AND A SUGGESTION OF LOOSENING OF TIBIAL COMPONENT. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2020. THE PROVIDER RECOMMENDED REVISION TO IMPLANT WITH STEMMED TIBIAL COMPONENT. PATIENT WAS REVISED ON (B)(6) 2021 WITH EXACTECH COMPONENTS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 16560010 ↗
• InjuryMar 14, 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 72 YO WHITE MALE PATIENT EXPERIENCED INCREASING PAIN DISCOMFORT IN RIGHT ANKLE, AFFECTING GAIT. CT SCAN SHOWS LARGE PERIPROSTHETIC CYSTIC LUCENCIES ADJACENT TO TIBIAL TRAY. SEVERE POSTERIOR SUBTALAR JOINT ARTHROSIS. THE DATE OF ONSET IS (B)(6) 2020 . THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020 . THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2020 .

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Discomfort; Implant Pain; Pain

  MAUDE report 16542144 ↗
• InjuryJan 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A RIGHT TOTAL ANKLE ARTHROPLASTY DUE TO END-STAGE ARTHRITIS WITH ASSOCIATED EQUINUS CONTRACTURE AND PERSISTENT PAIN ASSOCIATED WITH PREVIOUS ANKLE HARDWARE. ON OR ABOUT (B)(6) 2019, PATIENT UNDERWENT RIGHT ANKLE REVISION DUE TO A FAILED RIGHT TOTAL ANKLE REPLACEMENT. SURGEON INDICATED IN HIS OPERATIVE REPORT THAT THE PATIENT'S "CLINICAL EXAM AND RADIOGRAPHS DEMONSTRATED LOOSENING OF THE TIBIAL COMPONENT." DURING THE PATIENT'S RIGHT TOTAL ANKLE REVISION SURGERY ON OR ABOUT (B)(6) 2019, SURGEON PERFORMED A REVISION OF THE PATIENT'S RIGHT ANKLE ARTHOPLASTY AND IMPLANTED A COMPETITOR'S ANKLE COMPONENTS.

  Patient problems: Failure of Implant

  MAUDE report 16092514 ↗
• InjuryFeb 15, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 2 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 11330175 ↗
• InjuryFeb 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 YEARS POSTOP THE INITIAL RIGHT ANKLE IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT EXPERIENCED TIBIAL LOOSENING AND WAS REVISED. PATIENT IS DOING WELL NOW. REMOVAL OF VANTAGE IMPLANT. THE PATIENT HAS A HISTORY OF POST-TRAUMATIC ARTHRITIS AND HYPERTENSION. NO OTHER INFORMATION AVAILABLE AS REVISION WAS COMPLETED OUT OF THE CLINICAL STUDY. DEVICE IS NOT RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 11324004 ↗
• InjuryFeb 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 2.5 YEARS POSTOP THE INITIAL RIGHT ANKLE IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT EXPERIENCED TIBIAL LOOSENING AND WAS REVISED. PATIENT HAS A HISTORY OF POST TRAUMATIC ARTHRITIS, OSTEOPOROSIS, AND HYPERTENSION. PATIENT IS DOING WELL NOW. REMOVAL OF VANTAGE IMPLANT. NO OTHER INFORMATION AVAILABLE AS REVISION WAS COMPLETED OUT OF THE CLINICAL STUDY. DEVICE IS NOT RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 11323996 ↗
• InjuryFeb 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 YEARS POSTOP THE INITIAL RIGHT ANKLE IMPLANT, THIS (B)(6) MALE PATIENT EXPERIENCED TIBIAL LOOSENING AND WAS REVISED. PATIENT IS DOING WELL NOW. REMOVAL OF VANTAGE IMPLANT. THE PATIENT HAS A HISTORY OF POST-TRAUMATIC ARTHRITIS. NO OTHER INFORMATION AVAILABLE AS REVISION WAS COMPLETED OUT OF THE CLINICAL STUDY. DEVICE IS NOT RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 11323950 ↗
• InjuryDec 29, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE (B)(6) MALE PATIENT PRESENTED WITH PAIN "LIKE BEFORE MY SURGERY" AFTER BEGINNING A WALKING PROGRAM. PATIENT¿S BMI IS (B)(6), WEIGHT IS (B)(6). X-RAYS SHOW CYST FORMATION AND EARLY LOOSENING IN RIGHT ANKLE. THE PATIENT WAS INSTRUCTED TO REDUCE WALKING AND RETURN IN 2 MONTHS. PATIENT HAS A HISTORY OF POST TRAUMATIC ARTHRITIS, HYPERTENSION, A-FIB; PAD; H/O PULMONARY EMBOLISM & SKIN CANCER. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 11086722 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING A GASTROCNEMIUS-SOLEUS RECESSION UNDER FLUOROSCOPY PROCEDURE ON THIS (B)(6) Y/O FEMALE WHO IS INSULIN DEPENDENT DIABETIC AND HAS HISTORY OF POST TRAUMATIC ARTHRITIS, EXPERIENCED A TWO PART FRACTURE OF THE MEDIAL MALLEOLUS OCCURRED DURING THE PROCEDURE, AND WAS FIXED WITH A HOOK PLATE AND BONE GRAFT. SURGEON WILL FOLLOW UP WITH AN AE CHECK AFTER 3 MONTHS TO DETERMINE IF EVENT IS RESOLVED. THERE ARE NO DEVICES TO BE RETURNED. THE CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 10458702 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem

  INDEX SURGERY: (B)(6) 2019. DISTAL FIBULAR FRACTURE (JUST LATERAL TO TIBIAL COMPONENT), WHICH LIKELY OCCURRED INTRA-OPERATIVELY. DIAGNOSED AT 6 WEEK POST-OP VISIT BY X-RAY EVALUATION AND ASSOCIATED PAIN. NO ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 8658960 ↗

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