EVOLUTION® E2004028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684E20040281), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryAug 10, 2023Break; Break

  ALLEGEDLY, THE INSTRUMENT WAS USED WITH THE APPROPRIATE MANOR WITH THE REQUIRED TIBIAL TRAY AND IMPACTED INTO THE BONE. BROACHING WAS UNDERTAKEN BUT THE TIBIAL PUNCH TOWER SEEEMED TO RAISE OFF THE TIBIAL BASE PLATE. PUSHING DOWN THE TOWER THE TIBIAL KEAL WAS SEATED AND BOTTOMED OUT. WHEN COUNTING THE INSTRUMENTS BACK INTO THE TRAYS IT WAS NOTICED THAT THE POSTERIA LATERAL PEG WAS MISSING FROM E2004028. THIS WAS AFTER CEMENTED IMPLANTATION AND AT THE TIME OF SEWING UP. NO METAL REMNANT WAS SEEN PROTRUDING FROM OR INSIDE THE PULSE LAVAGED TIBIAL SURFACE PRIOR TO CEMENTING THE TIBIAL PLATE. THE PATIENT WAS XRAYED IMMEDIATELY POST OP TO CHECK FOR THE PEG REMNANT. IT WAS NOT SEEN IN THE SOFT TISSUE NORE WAS IT SEEN IN THE BONE ON AN AP & LAT BUT IT COULD OBSTRUCTED BY THE METAL KEEL OF THE TIBIAL PLATE.

  Patient problems: Insufficient Information

  MAUDE report 17500122 ↗