LEGION 71434395Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556033791), received between Jul 15, 2019 and Feb 1, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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.

• MalfunctionFeb 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TRAIL STAGE OF HK PROCEDURE, THE LEG WAS NOT REACHING FULL EXTENSION. THE TRIALS USED WERE: LEGION HINGE TIB BASE TRL SZ 5 RT, LEGION HINGE 11MM TRIAL POST AND LGN HINGE TRIAL LINK SZ 6-7. WITH THE TRIAL IMPINGING AND BLOCKING THE KNEE FROM ACHIEVING FULL EXTENSION, IT APPEARED LIKE THE KNEE WAS UNBALANCED AND TIGHT IN EXTENSION THEREFORE BONE RE CUTS WERE MADE TO BALANCE THE KNEE. THEY RE-CUT THE FEMUR AND RE-TRIAL, BUT THERE WAS NO IMPROVEMENT. ALSO THEY RE-CUT THE TIBIA AND RE-TRIAL AND THERE WAS NO IMPROVEMENT. BUT THESE RE-CUTS MADE NO DIFFERENCE TO THE ROM OF THE KNEE. GAP ASSESSMENT TOOL INDICATED THAT THERE SHOULD BE NOT ISSUE ACHIEVING FULL EXTENSION. HOWEVER THE SURGEON THEN SUGGESTED THE TRIAL ITSELF WAS MECHANICALLY RESTRICTING THE ROM. TRAIL WAS REMOVED AND RECONSTRUCTED OUTSIDE THE PATIENT AND CONFIRMED THAT THE TRAIL WAS LIMITING THE EXTENSION. THE PROCEDURE WAS COMPLETED. AFTER THE CASE THE REP REBUILT WITH ASSISTANCE FROM A MEMBER OF THE THEATRE TEAM, WITH A COUPLE OF FAILED ATTEMPTS WITH THE SAME ISSUE. THE TRIAL WAS ASSEMBLED WITH NORMAL FUNCTION. THEREFORE IT WAS DETERMINED THAT THE BOLT AT SOME POINT HAD BEEN CROSS-THREADED AND IF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277854 ↗
• InjuryJul 15, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON BELIEVED THE TRIAL COMPONENT PARTS WERE ADEQUATELY LOCKED TOGETHER DURING A TRIAL REDUCTION. LATER DETERMINED THEY WERE NOT, RESULTING IN THE NEED FOR 5MM FEMORAL AUGMENTS. FINAL POLY INSERT IMPLANT WAS ALSO EXCHANGED FOR A LARGER SIZE. LESS THAN 30 MINUTES DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8791755 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a