LEGEND II 2490-46-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295125884), received between Mar 12, 2020 and Mar 15, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2021Break; Material Twisted/Bent; Mechanical Jam; Break; Material Twisted/Bent; Mechanical Jam

  BROKEN AND WORN LCS MILESTONE TIBIAL JIG. THE SILVER LOCKING KNOB ON THE ANKLE CLAMP WAS JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11487947 ↗
• MalfunctionFeb 9, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ALL THESE INSTRUMENTS ARE WORN DOWN FROM MANY YEARS OF FREQUENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305474 ↗
• MalfunctionFeb 9, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ALL THESE INSTRUMENTS ARE WORN DOWN FROM MANY YEARS OF FREQUENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305473 ↗
• MalfunctionFeb 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ALL THESE INSTRUMENTS ARE WORN DOWN FROM MANY YEARS OF FREQUENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297965 ↗
• MalfunctionJun 11, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DRAGON TOOTH TIBIA. SLOT WHERE SLAP HAMMER ATTACHES MUST HAVE A BURR AS IT DOESN'T RELEASE EASILY. RELEASED WHEN TAPPED WITH MALLET. 7 DEGREE CUTTING BLOCK. ONE OF THE HOLES DOESN'T ACCEPT PIN. MUST BE BURRED. PICKED A DIFFERENT HOLE WHICH ACCEPTED THE PIN. NO ADVERSE EVENTS TO REPORT. OCCURRED DURING SURGERY. REP PRESENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10143830 ↗
• MalfunctionMar 12, 2020Break; Material Twisted/Bent; Naturally Worn; Physical Resistance/Sticking; Break; Material Twisted/Bent; Naturally Worn; Physical Resistance/Sticking

  BROKEN AND WORN TIBIAL JIG LCS. WOULD NOT EXTEND DURING SURGERY, LOCKING MECHANISM WAS JAMMED, 10 MINUTE DELAY WHILST ALTERNATIVE KIT SOURCED. PIN PULLER THE SPRING HAS WORN AND A NEW ONE IS REQUIRED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9823906 ↗