Series 7000 7115-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327033328), received between Jun 25, 2018 and Dec 17, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2018Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY WAS REPORTED TO THE REP. THE FEMORAL COMPONENT, INSERT, AND CEMENTED TIBIA WERE REVISED. NONE OF THE RECORDS ACCESSIBLE TO REP CONFIRMED THE MANUFACTURER OF THE CEMENT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury

  MAUDE report 8169207 ↗
• InjuryJun 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. SURGEON REPORTED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. REP WAS NOT MADE AWARE OF THE SEVERITY OF, OR ANY PATIENT FACTORS THAT COULD BE ATTRIBUTED TO PAIN. PATIENT WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT.

  Patient problems: Injury; Pain

  MAUDE report 7635287 ↗