Series 7000 7115-0011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327033380), received between Mar 19, 2021 and Mar 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 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.

• InjuryMar 19, 2021Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "DR..PERFORMED A RIGHT KNEE REVISION DUE TO LOOSENING." A SENES 7000 TIBIAL COMPONENT, SCORPIO-FLEX TIBIAL INSERT, AND CR FEMORAL COMPONENT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER, AND THE FEMORAL COMPONENT WAS REVISED TO CONVERT TO A DIFFERENT KNEE SYSTEM. SPOKE TO REP: CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11523072 ↗