Vantage 350-22-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862276377), received between Dec 20, 2022 and Mar 4, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 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 43-YEAR-OLD FEMALE PATIENT HAD A RIGHT TAA ON (B)(6) 2018/ AND PRESENTED WITH INFECTION AND PAIN. ON (B)(6) 2018 PATIENT PRESENTED WITH SUPERFICIAL SKIN INFECTION AND DELAYED WOUND HEALING THAT WAS TREATED WITH MEDICATION AND RESOLVED ON (B)(6) 2018. ON (B)(6) 2018, PATIENT UNDERWENT PROCEDURE, ANKLE DEBRIDEMENT FOR MEDIAL GUTTER IMPINGEMENT AND NEUROPLASTY OF SURAL NERVE DUE TO PAIN/NERVE ENTRAPMENT, MARKED AS RESOLVED ON (B)(6) 2018. FOLLOWING ON (B)(6) 2019 THE PATIENT WAS REVISED FOR ONGOING INFECTION AND PAIN, PLUS THE OTHER AES. MARKED AS RESOLVED ON (B)(6) 2019. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED BY REVISION ON (B)(6) 2019. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY 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: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 18833762 ↗
• InjuryOct 11, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT ANKLE REPLACEMENT ON (B)(6)2021. APPROXIMATELY 1 YEAR AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT ANKLE REVISION ON (B)(6) 2022. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE PAIN, SWELLING, INSTABILITY, FALLS, SCAR TISSUE, AND WEAKNESS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTID

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Insufficient Information; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 17914180 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL THAT A FEMALE PATIENT HAD AN INITIAL RIGHT ANKLE REPLACEMENT PROCEDURE ON (B)(6) 2019 AT AGE 56 YO AND HAD A REVISION ON (B)(6) 2021. REVISION WAS NOTED TO BE FOR FLEXOR DIGITORUM LONGUS TEAR; MEDIAL GUTTER IMPINGEMENT; PERIPROSTHETIC CYST AT THE TALAR COMPONENT; INSTABILITY; DIFFICULTY GETTING TO NEUTRAL DORSIFLEXION; DIFFICULTY WALKING AND WEIGHT-BEARING; STIFFNESS, LOSS OF MOVEMENT AND FLEXIBILITY; PAIN AT THE POSTERIOR ASPECT, TIGHTNESS IN THE POSTERIOR ASPECT; SWELLING OF THE ANKLE. CURRENT REPORTED CONDITION OF PATIENT-RIGHT ANKLE PAIN AND LOSS OF RANGE OF MOTION, NON-WEIGHT BEARING, USE OF CRUTCHES, PAIN MEDICATION, BACK AND NECK PAIN DUE TO ABNORMAL GAIT. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 16016681 ↗

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-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