Evolution ETPKN3SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684ETPKN3SR1), received between Mar 24, 2020 and Mar 24, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2020Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  ALLEGEDLY, ASEPTIC LOOSENING ,CS AND PS TYPE IMPLANTS WERE INCLUDED ON BOTH SIDES AND PATIENT HAD JOINT INSTABILITY , THE INSERTS HAD ABNORMAL WEAR PATTERNS AND SOME DISCOLORATION. (B)(6).

  Patient problems: No Information

  MAUDE report 9872386 ↗
• InjuryMar 24, 2020Material Discolored; Loose or Intermittent Connection; Unstable; Loss of Osseointegration; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration

  ALLEGEDLY, ASEPTIC LOOSENING, CS AND PS TYPE IMPLANTS WERE INCLUDED ON BOTH SIDES. ONLY PS WAS REVISED, PATIENT HAD JOINT INSTABILITY, THE INSERTS HAD ABNORMAL WEAR PATTERNS AND SOME DISCOLORATION. (B)(6).

  Patient problems: No Information

  MAUDE report 9871788 ↗