PROFIX 71502220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010219268), received between Sep 30, 2022 and Sep 30, 2022 — 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.

• InjurySep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKR SURGERY, THE PATIENT SUFFERED A FALLING IN MAY 2020 AND SINCE THEN, EXPERIENCED PAIN, RECENTLY IT WAS DETECTED A METALIC FRAGMENT IN X-RAY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. DURING SURGERY WAS FOUND A FRACTURE IN THE FEMORAL COMPONENT IN FRAGMENTS, THE DEVICE WAS CHANGED AND PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: Failure of Implant; Fall; Implant Pain

  MAUDE report 15519159 ↗