LEGION 71434306Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010547989), received between Jul 15, 2018 and Jul 1, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A LEGION TKA REVISION SURGERY, ONE (1) LGN OFFSET COUPLER TRIAL 6MM WAS STUCK AND DID NOT ROTATE 180 DEGREES. DUE TO THE INABILITY TO PERFORM A TRAILING WITH THE LGN OFFSET COUPLER TRIAL 6MM, WHICH HAD ALREADY BEEN USED FOR THE BONE CUTS, IT WAS DECIDED TO PASS ONE (1) LGN OFFSET COUPLER 6MM, HOWEVER, IT DID NOT MATCH THE ANATOMIC STRUCTURE, THEREFORE, IT WAS REMOVED FROM THE PATIENT AND THE EXCESS CEMENT WAS CLEANED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH MANUAL ADJUSTMENTS, USING A 4MM COUPLER. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373443 ↗
• MalfunctionApr 23, 2025Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) LGN OFFSET COUPLER TRIAL 6MM WOULDN'T LOCK INTO THE FEMUR AND THE SCREW FELL OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896356 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) LGN OFFSET COUPLER TRIAL 6MM BROKE AT ITS BASE, WHEN REMOVING THE TRIAL PROSTHESIS, LEAVING THE OFFSET AND STEM IN THE MEDULLARY CANAL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. AN INTRAMEDULLARY OSTEOTOMY HAD TO BE PERFORMED, TO REACH THE OFFSET AND REMOVE IT WITH A PLIER. THE PATIENT'S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707963 ↗
• MalfunctionOct 11, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA, WHILE REMOVING THE LGN OFFSET COUPLER TRIAL 6MM, IT BROKE. THE REMOVAL OF THE BROKEN OFF PART TOOK LESS THAN 30 MINUTES, NOTHING WAS LEFT INSIDE THE PATIENT¿S BODY, AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429038 ↗
• MalfunctionApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVISION SURGERY PERFORMED DUE TO THE FAILURE OF COMPETITOR'S DEVICES, THE SCREW THAT ALLOWS THE SWIVELING OF ONE (1) LGN OFFSET COUPLER TRIAL 6MM BROKE DURING IMPACTION. THIS LED TO THE STEM BEING STUCK IN THE FEMUR; HOWEVER, IT WAS EVENTUALLY REMOVED AFTER A FEW ATTEMPTS. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT USING A MIDAS REX AND AN OSTEOTOME. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052431 ↗
• MalfunctionOct 23, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LGN OFFSET COUPLER TRIAL 6MM SNAPPED OFF WHEN SURGEON WAS MALLETING TIBIA AND FELL IN THE FLOOR. NO PIECES FELL INTO THE PATIENT. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984603 ↗
• MalfunctionOct 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) LGN OFFSET COUPLER TRIAL 6MM BROKE WHEN IT WAS STRIKING WITH MALLET ON TIBIA. THE COUPLER SNAPPED OFF AND FELL ONTO THE FLOOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957202 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LGN OFFSET COUPLER TRIAL 6MMF INSIDE OF COUPLER BROKE AND FELL OUT ON THE FLOOR. NO PIECES FELL INTO 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 13114532 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT THE LEGION OFFSET COUPLER TRIAL 6MM HAD SEVERE STRIPPING. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860159 ↗
• MalfunctionMar 14, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER PROCEDURE, A LOOSENED LOCKING SCREW ON THE LGN OFFSET COUPLER TRIAL 6MM CAME OUT WHEN IT WAS SCRUBBED. THERE WAS NO PATIENT INVOLVED WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478826 ↗
• MalfunctionMar 8, 2021Loose or Intermittent Connection; Component Missing; Loose or Intermittent Connection; Component Missing

  IT WAS REPORTED THAT, DURING THE STERILE PROCESSING, THE LOCKING SCREW OF A 6MM LEGION OFFSET COUPLER IS MISSING AND COUPLER CANNOT BE LOCKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431785 ↗
• MalfunctionDec 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, THREADS ON THE LEGION OFFSET COUPLER TRIAL 6 MM, WERE NOTICED TO BE WORN OUT AND WOULD NOT LOCK. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY OR AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094991 ↗
• MalfunctionDec 28, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A REVISION SURGERY (REVISION OF A ZIMMER TOTAL KNEE) THE LGN OFFSET COUPLER TRIAL 6MM MISSED A SCREW ON THE INSIDE AND WOULD NOT ATTACH TO OTHER TRIAL REVISION INSTRUMENTS. THERE WAS NO DELAY. A S&N BACK UP INSTRUMENT WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES 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

  MAUDE report 11077881 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND BROKEN. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10668002 ↗
• InjuryOct 7, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING RT TOTAL KNEE REVISION, SURGEON HAD DIFFICULTY TIGHTENING LEGION OFFSET COUPLER TRIAL, WAS UNABLE TO USE TRIAL 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10641465 ↗
• MalfunctionFeb 14, 2020Break; Break

  IT WAS REPORTED THAT DURING AN S AND N KNEE REVISION, THE COUPLER WASN'T ENGAGING ONE OF THE WASHERS WITHIN THE COUPLER WAS BROKEN. NO INJURIES OR DELAYS REPORTED. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714437 ↗
• InjuryFeb 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN S+N KNEE REVISION THE COUPLER BROKE AS THE SURGEON WAS TAKING THE TRIAL FEMORAL COMPONENT OUT OF THE PATIENT. NO PIECES WERE LEFT INTO THE PATIENT. NO INJURIES OR DELAYS REPORTED. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9656955 ↗
• 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 8357788 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT ITEM BROKE IN STEM TRIAL DURING SURGERY. USED AN IDENTICAL BACKUP DEVICE TO COMPLETE SURGERY. SURGERY TIME WAS NOT EXTENDED MORE THAN 30 MIN. THE SURGEON DOES NOT FAULT THE DEVICE. THE PATIENT OR SURGICAL PROCEDURE WAS NOT AFFECTED IN ANYWAY DUE TO THE PROBLEM. NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 7754695 ↗
• MalfunctionJul 25, 2018Break; Break

  ITEM BROKE DURING SURGERY. USED AN IDENTICAL BACKUP DEVICE TO COMPLETE SURGERY. SURGERY TIME WAS NOT EXTENDED MORE THAN 30 MIN. THE SURGEON DOES NOT FAULT THE DEVICE. THE PATIENT OR SURGICAL PROCEDURE WAS NOT AFFECTED IN ANY WAY DUE TO THE PROBLEM. NO BROKEN PIECES FELL INTO OR WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7720914 ↗
• InjuryJul 15, 2018Fracture; Fracture

  DR NEEDED TO REMOVE THE TRIAL, USING THE SLAP HAMMER, DR REALIZED THE FEMORAL COMPONENT CAME AWAY FROM THE BONE, WITHOUT THE STEM AND OFFSET COUPLER. ON INVESTIGATION WE REALIZED THE COUPLER HAD BROKEN, PART IN THE FEMORAL TRIAL AND PART IN THE TRIAL STEM IN THE MEDULLARY CANAL. HE NEEDED TO REMOVE SOME BONE FROM THE ANTERIOR CORTEX TO GAIN ACCESS TO THE END OF THE CONSTRUCT TO ENABLE HIM TO GRIP IT WITH BONE NIBBLERS AND REMOVE IT. ON FURTHER EXAMINATION WE REALIZED THE LOCKING SCREW IN THE COUPLER HAD FRACTURED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7688786 ↗

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