VARIAX 626976Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327170887), received between May 27, 2021 and May 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2021Fracture; Fracture

  A PATIENT (WHO POINTED OUT SHE IS AN RN) SAID THAT SHE HAD A TITANIUM IMPLANT PLACED IN HER GREAT TOE LAST OCTOBER AND IT IS NOW CRACKED. SHE ASSUMES THIS WILL NEED A REVISION SURGERY. SHE WOULD LIKE TO KNOW HOW A TITANIUM IMPLANT CRACKED. UPDATE-PHONE CALL WITH PATIENT (B)(6)2021 PATIENT WENT IN FOR A FOLLOW UP ON (B)(6)2021 AND HER PHYSICIAN FOUND A CRACK IN THE TITANIUM PLATE ON HER LEFT GREAT TOE. A CARTIVA IMPLANT WAS REMOVED TO PUT IN A STRYKER IMPLANT. PATIENT INDICATED THAT SHE CALLED AND LEFT A VOICE MAIL FOR THE CARTIVA COMPLAINT BUT HAD NOT HEARD BACK FROM ANYBODY. PATIENT WAS NON-WEIGHT BEARING FOR THREE MONTHS POST OPERATIVELY. THE PATIENT WOULD LIKE TO KNOW WHY THIS HAPPENED. THE PATIENT HAS BEEN USING A BONE STIMULATOR SINCE THE OPERATION AND HER PHYSICIAN ADVISED SHE CONTINUE TO USE IT FOR AN ADDITIONAL FOUR WEEK TO ASSESS IF THERE IS ADDITIONAL DAMAGE TO THE BONE OR THE BONE STABILITY. HER PHYSICIAN WOULD DETERMINE AT THIS FOUR-WEEK MARK IF A REVISION IS NEEDED. UPDATE (B)(6)2021 PHONE CALL WITH PATIENT, SHE INDICATED THAT A REVISION OF THE DEVICE MIGHT HAPPEN.

  Patient problems: Failure of Implant

  MAUDE report 11894987 ↗