Legion 71442013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556537176), received between Oct 21, 2025 and Oct 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K162775); they may or may not involve this specific model.

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.

• MalfunctionOct 22, 2025Difficult to Insert; Separation Failure; Material Twisted/Bent; Difficult to Insert; Separation Failure; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A LEGION REVISION SURGERY IN THE LEFT KNEE, IT WAS NOTICED THAT ONE (1) LGN TIB CONE IMPCTR HNDL 4MM OFFST SLEEV WAS NOT INSERTING IN ONE (1) LGN CONE IMPACTOR HANDLE. THE SLEEVE WAS NOT DEPRESSING, NOR ENGAGING IN THE HANDLE, IT WOULDN'T FULLY SEAT. IT WAS UNCLEAR WHETHER THIS WAS DUE A FAULT WITH THE SLEEVE OR THE HANDLE, HOWEVER AFTER THE CASE IT WAS NOTICED THE SLEEVE SEEMED BENT. DURING THE CASE THE SURGEON HAD TO HIT THE SLEEVE TO GET IT TO ENGAGE IN THE BROACH HANDLE, THIS ITSELF REQUIRED A LOT OF FORCE; THE SURGEON REPORTED HE HIT HIS FINGERS A NUMBER OF TIMES WHICH WAS PAINFUL. AFTER HITTING THE SLEEVES A NUMBER TIMES, THE SURGEON MANAGED TO SEAT THE SLEEVE IN THE CONE BROACH HANDLE. HE WAS THEN ABLE TO BROACH TO THE REQUIRED CONE SIZE. DUE TO HOWEVER IMPACTING THE SLEEVE INTO THE BROACH HANDLE SO HARD IT BECAME WELDED IN THE BROACH HANDLE WHICH RESULTED IN THE 4MM SLEEVE GETTING STUCK. LATER ON IN THE SURGERY, WHEN PREPARING THE FEMUR, THE SURGEON NEEDED FEMORAL CONES FOR METAPHYSEAL FIXATION. AS NO OFFSET CAN BE USED WITH CONES, THE 4MM OFFSET BEING STUCK IN THE BROACH HANDLE WAS A SERIOUS PROBLEM. THE SURGEON AGAIN MANAGED TO HAMMER THE SLEE

  Patient problems: Pain

  MAUDE report 23360818 ↗
• MalfunctionOct 21, 2025Positioning Failure; Separation Failure; Material Twisted/Bent; Positioning Failure; Separation Failure; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A LEGION REVISION SURGERY IN THE LEFT KNEE, IT WAS NOTICED THAT ONE (1) LGN TIB CONE IMPCTR HNDL 4MM OFFST SLEEV WAS NOT INSERTING IN ONE (1) LGN CONE IMPACTOR HANDLE. THE SLEEVE WAS NOT DEPRESSING, NOR ENGAGING IN THE HANDLE, IT WOULDN'T FULLY SEAT. IT HAD TO HIT THE SLEEVE TO GET IT TO ENGAGE IN THE BROACH HANDLE. AFTER HITTING THE SLEEVES A NUMBER OF TIMES, THE SURGEON MANAGED TO SEAT THE SLEEVE IN THE CONE BROACH HANDLE. DUE TO HOWEVER IMPACTING THE SLEEVE INTO THE BROACH HANDLE SO HARD IT BECAME WELDED IN THE BROACH HANDLE WHICH RESULTED IN THE 4MM SLEEVE GETTING STUCK. LATER ON IN THE SURGERY, WHEN PREPARING THE FEMUR, IT WAS NEEDED FEMORAL CONES FOR METAPHYSEAL FIXATION. AS NO OFFSET CAN BE USED WITH CONES, THE 4MM OFFSET BEING STUCK IN THE BROACH HANDLE WAS A SERIOUS PROBLEM. THE SURGEON AGAIN MANAGED TO HAMMER THE SLEEVE OUT. DUE TO THE BROACH HANDLE BEING FAULTY AND ONE (1) LGN CONE IMPCTR HNDL NEUTRAL SLEEVE ALSO NOT DEPRESSING INTO THE HANDLE, THE SURGEON HAD TO BROACH AND INSERT TRIAL AND DEFINITIVE IMPLANT USING THE BROACH WITHOUT A SLEEVE. THE PROCEDURE WAS COMPLETED, AFTER A DELAY OF ONE HOUR, USING THE SAME DEVICES. THIS EVENT INCREASED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349548 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162775. One submission often covers many models, so check the product and lot details in each record.

• Z-2625-2017 · May 30, 2017 · Terminated
  LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
• Z-2624-2017 · May 30, 2017 · Terminated
  LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM