Series 7000 7115-0006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327033359), received between Jun 11, 2019 and Jun 11, 2019 — 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.

• InjuryJun 11, 2019Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PAINFUL RIGHT TOTAL KNEE ARTHROPLASTY 2008 SECONDARY TO FLEXION INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT. SEVERE POLYETHYLENE WEAR LATERAL TIBIAL PLATEAU OF THE ARTICULAR COMPONENT WITH ASSOCIATED SYNOVITIS".

  Patient problems: Inadequate Osseointegration; Injury; Pain; Synovitis

  MAUDE report 8686515 ↗