LEGION 71434302Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010547965), received between Jan 3, 2019 and Jun 9, 2022 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SURGERY, AN LGN OFFSET COUPLER TRIAL 2MM IN THE REVISION SET DID NOT HAVE THE INNER SCREW WHICH TIGHTENS THE COUPLER TO THE REVISION BASEPLATE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640422 ↗
• MalfunctionJun 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SURGERY, TWO (2) LGN OFFSET COUPLER TRIAL 2MM IN THE REVISION SET DID NOT HAVE THE INNER SCREW WHICH TIGHTENS THE COUPLER TO THE REVISION BASEPLATE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640269 ↗
• MalfunctionMay 10, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA, A LGN OFFSET COUPLER TRIAL 2MM DID NOT FUNCTION CORRECTLY. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798469 ↗
• MalfunctionApr 11, 2021Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, A LEGION OFFSET COUPLER TRIAL 2MM WOULD NOT TIGHTEN PROPERLY DURING A TKA AND THE DEVICE IS MISSING A SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646908 ↗
• MalfunctionDec 15, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, THERE WAS A MISSING SET SCREW IN THE LEGION OFFSET COUPLER TRIAL 4MM SET AND THE LGN OFFSET COUPLER TRIAL 2MM SET SCREW DOES NOT TIGHTEN. NO CASE REPORTED THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008203 ↗
• MalfunctionNov 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING PROCEDURE, LEGION OFFSET COUPLER TRIAL 2MM WAS NOTICED TO BE WITHOUT THE LOCK. PROCEDURE WAS CONCLUDED WITH THE SAME DEVICE, WITHOUT A DELAY OR AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10879183 ↗
• InjuryOct 1, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING RT TOTAL KNEE REVISION, SURGEON HAD DIFFICULTY TIGHTENING BOTH LEGION OFFSET COUPLER TRIAL 2MM, WERE UNABLE TO USE TRIALS DURING SURGERY. SURGEON MADE THE DECISION TO USE TRIAL STEMS WITHOUT ANY OFFSET COUPLER TRIAL. TRIAL REDUCTION AND TRIAL COMPONENT FIT SEEMED APPROPRIATE. THE SURGERY FINISHED WITHOUT ANY FEMORAL OR TIBIAL OFFSET COUPLER. NOT S+N IMPLANTS BEING REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10617505 ↗
• InjuryOct 1, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING RT TOTAL KNEE REVISION, SURGEON HAD DIFFICULTY TIGHTENING BOTH LEGION OFFSET COUPLER TRIAL 2MM, WERE UNABLE TO USE TRIALS DURING SURGERY. SURGEON MADE THE DECISION TO USE TRIAL STEMS WITHOUT ANY OFFSET COUPLER TRIAL. TRIAL REDUCTION AND TRIAL COMPONENT FIT SEEMED APPROPRIATE. THE SURGERY FINISHED WITHOUT ANY FEMORAL OR TIBIAL OFFSET COUPLER. NOT S+N IMPLANTS BEING REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10617397 ↗
• InjuryAug 3, 2020Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY OF ZIMMER UNI KNEE THE LGN OFFSET COUPLER TRIAL 4MM BROKE WHILE INSIDE THE PATIENT, PIECES WERE EXTRACTED FROM THE MEDULLARY CANAL USING GENERAL INSTRUMENTS. THERE WAS A DELAY OF 90 MINS. OTHER INSTRUMENT IN THE SET WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10356935 ↗
• MalfunctionMay 6, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE 2MM OFFSET COUPLER IS STUCK IN THE 5L HINGE FEMORAL TRIAL. NO INJURIES OR DELAYS REPORTED. BACK UP AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582538 ↗
• MalfunctionFeb 21, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN STARTING A PRIMARY SURGERY AT A PATIENT WITH SEVERE VARUS DEFORMATION, WHEN THE NURSE TRIED TO PREPARE THE INSTRUMENTS, IT WAS NOTED THAT THE INSTRUMENT WAS NOT CLEAN INSIDE, AFTER MULTIPLE CLEANING AND DISINFECTION IN THE RDG, THIS SHOWN TO HAVE ROUGH REMEDIES AND RESIDUAL PROTEINS. THE PATIENT HAD ALREADY A SPINAL ANESTHESIA, AND THE PLANNED SURGERY HAD TO BE CANCELED DUE TO THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357735 ↗
• MalfunctionFeb 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE COUPLER BROKE IN TWO PIECES. NO DELAY REPORTED. BACKUP DEVICE AVAILABLE. NO IMPACT TO PATIENT REPORTED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306984 ↗
• MalfunctionJan 3, 2019Break; Break

  IT WAS REPORTED THAT DEVICE BROKE DURING AN UNSPECIFIED PROCEDURE. THERE WAS A BACKUP DEVICE AVAILABLE AND THE PROCEDURE WAS NOT DELAYED. IT IS UNKNOWN IF THERE WAS AN IMPACT TO THE PATIENT DUE TO THIS ISSUE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8212964 ↗

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