Vantage 350-22-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862276346), received between Jun 22, 2022 and Jun 3, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 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.

Recalls naming this device

1. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0024-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A POLY EXCHANGE AND A SURGICAL PROCEDURE FOR ANKYLOSIS THAT WAS CAUSING PAIN APPROXIMATELY 3 YEARS 7 MONTHS AFTER IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- RIGHT ANKLE REPLACEMENT WITH POLYETHYLENE EXCHANGE/RIGHT ACHILLES LENGTHENING. WORK-UP SHOWED NO LOOSENING OF THE IMPLANT BUT RATHER SIGNIFICANT BONE FORMATION PARTICULARLY ON THE LATERAL GUTTER WHICH ANKYLOSED THE DISTAL FIBULA TO THE TALUS, NO INFECTION. SURGEON EXPLAINED THAT THEY MIGHT NOT BE ABLE TO OBTAIN NORMAL MOTION BUT WOULD HELP WITH PAIN. SUBSTANTIAL SCARRING AT THE FRONT OF ANKLE. THE LATERAL AND MEDIAL GUTTER WAS COMPLETELY BRIDGED WITH BONE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ankylosis; Arthralgia

  MAUDE report 19451793 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL ANKLE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PERIPROSTHETIC CYSTS (TIBIA AND TALUS). REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19319569 ↗
• InjuryMar 11, 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 64-YEAR-OLD FEMALE PATIENT HAD AN INITIAL RIGHT TAA ON (B)(6) 2018 CAPTURED ON (B)(4) WITH A REVISION TO THE ANKLE (B)(6) 2022. THE PATIENT PRESENTED WITH PAIN, 1 YEAR(S) AND 3 MONTH(S) POST PROCEDURE ON (B)(6) 2023. THE PATIENT REPORTS TRAVELING THROUGH THE (B)(6) IN (B)(6) APPROXIMATELY 4 WEEKS AGO. DEVELOPED INCREASED PAIN AND SWELLING IN THE RIGHT ANKLE. PATIENT DENIES KNOWN INJURY OR TRAUMA AND REPORTS THE PAINS ARE PRIMARILY ALONG THE OUTSIDE OF THE ANKLE, BUT ALSO HAS SOME PAIN IN THE FRONT AND INSIDE OF THE ANKLE. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE REPORT INDICATES THAT THE ACTION TAKEN IS OTHER - ANTI-INFLAMMATORY MEDS - PRN, RECOMMEND WALKING BOOT TO PROVIDE SUPPORT. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18876978 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL ANKLE REPLACEMENT ON (B)(6) 2018. THE PATIENT PRESENTED WITH MEDIAL SYMPTOMS, MECHANICAL IN NATURE, BUT RELATED TO THE SUPERFICIAL PERONEAL NERVE. RADIOGRAPHS SHOW HETEROTOPIC OSSIFICATION OF MEDIAL GUTTER, CAUSING IMPINGEMENT. THE PATIENT WAS REVISED ON (B)(6) 2022, AND THE TIBIAL INSERT AND LOCKING CLIP WERE REPLACED. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Extraskeletal ossification; Failure of Implant; Joint Impingement; Pain

  MAUDE report 15419013 ↗
• InjuryJun 22, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY THE LEGAL BRIEF, PATIENT RECEIVED A RECALL NOTICE FOR HIS ANKLE PROSTHESIS MANUFACTURED BY EXACTECH LETTER DATED (B)(6) 2022. PATIENT SURGERY WAS ON JUNE 14, 2019.

  Patient problems: Implant Pain; Insufficient Information; Joint Impingement

  MAUDE report 14781850 ↗

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-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