LEGION 71434304Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010547972), received between Sep 26, 2017 and Apr 16, 2024 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LGN OFFSET COUPLER TRIAL 4MM HAS BROKEN INTO TWO PIECES WHILST IN USE. NO PIECES FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122528 ↗
• MalfunctionJan 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, WHEN LOCKING ONE (1) LGN OFFSET COUPLER TRIAL 4MM INTO THE DESIRED POSITION IT WAS NOTICED THAT THE SCREW TO LOCK IT WAS MISSING. ANOTHER 4MM TRIAL OFFSET WAS AVAILABLE TO USE ON THE FEMORAL TRIAL BUT IT WAS ALREADY SET IN PLACE ON THE TIBIAL TRIAL. THIS OTHER 4MM TRIAL OFFSET WAS TRANSFERRED TO THE FEMORAL TRIAL. BECAUSE ONLY ONE 4MM TRIAL OFFSET WAS WORKING A 2MM TRIAL OFFSET WAS USED ON THE TIBIAL TRIAL FOR THE PURPOSE OF A FULL KNEE TRIAL. A NON-SIGNIFICANT SURGICAL DELAY WAS CAUSED BY THIS EVENT. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571550 ↗
• InjuryNov 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LEGION OFFSET COUPLER TRIAL 4MM BROKE AND THE STEM TRAIL WAS STUCK IN THE FEMORAL MEDULLARY CANAL. SURGEON CREATED A WINDOW BY REMOVING THE BONE CHIP FROM THE ANTERIOR SIDE OF THE FEMUR TO PUSH THE STEM TRIAL FROM THE PROXIMAL PART, AND REMOVED IT FROM FEMORAL MEDULLARY CANAL AND THEN FIXED IT WITH AN ACCORD CABLE. PROCEDURE WAS DELAYED FOR AN HOUR. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Perforation

  MAUDE report 15740871 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT A LGN OFFSET COUPLER TRIAL 4MM IS BROKEN. SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518988 ↗
• MalfunctionJun 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE LGN OFFSET COUPLER TRIAL 4MM BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14663602 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT DURING TKA, THE THREAD OF THE LGN OFFSET COUPLER TRIAL 4MM BROKE OUTSIDE THE PATIENT. A SMITH AND NEPHEW BACK UP COUPLER WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655180 ↗
• InjuryMay 7, 2022Break; Break

  IT WAS REPORTED THAT UPON REMOVING THE TIBIAL TRIAL WITH THE LGN OFFSET COUPLER TRIAL 4MM IN POSITION DURING A TKA SURGERY, THE LGN OFFSET COUPLER TRIAL 4MM BROKE IN TWO AND LEFT THE STEM AND HALF THE OFFSET IN THE PATIENT AND THE TIBIAL TRIAL AND THE OTHER HALF OF THE OFFSET OUTSIDE. THEY MANAGED TO REMOVE THE BROKEN HALF THAT WAS IN THE PATIENT AND CARRIED ON WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324294 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT THE LGN OFFSET COUPLER TRIAL 4MM WAS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387486 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING KNEE ARTHROPLASTY, A LEGION OFFSET COUPLER TRIAL 4MM BROKE WHILE ASSEMBLING THE TRIAL COMPONENTS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136293 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT WHILE ASSEMBLING THE TRIAL COMPONENTS, THE LGN OFFSET COUPLER TRIAL 4MM BROKE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136270 ↗
• MalfunctionMay 7, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A TKA SURGERY A LGN OFFSET COUPLER TRIAL 4MM WAS UNABLE TO ATTACH TO THE TRIAL. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794853 ↗
• MalfunctionApr 19, 2021Break; Break

  IT WAS REPORTED THAT A LEGION OFFSET COUPLER TRIAL 4MM WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683752 ↗
• MalfunctionApr 19, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A LEGION OFFSET COUPLER TRIAL 4MM AND A LGN SCW POS WG TRL 5M SZ5-6LG WERE UNABLE TO ENGAGE THE LOCKING MECHANISM. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683739 ↗
• MalfunctionApr 11, 2021Component Missing; Connection Problem; Component Missing; Connection Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY OF A TKA PROCEDURE, THERE'S MISSING A SCREW PIECE IN THE J-HOOK SLOT, UNABLE TO LOOSEN OR TIGHTEN. THIS HAPPENED OUTSIDE THE PATIENT. THERE WAS A SLIGHT DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646918 ↗
• MalfunctionMar 29, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, FOR A LGN OFFSET COUPLER TRIAL 4MM, THE REAMER TRIAL WAS BENT AND UNABLE TO BE USED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586750 ↗
• MalfunctionMar 8, 2021Unstable; Component Missing; Naturally Worn; Unstable; Component Missing; Naturally Worn

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION PROCESS, WAS FOUND THAT THE LEGION OFFSET COUPLER TRIAL 4MM IS WORN AND LOOSE AS IT IS MISSING A SET SCREW. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431076 ↗
• MalfunctionFeb 28, 2021Break; Break

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY, OUTSIDE THE PATIENT, THE LEGION OFFSET COUPLER TRIAL 4MM BROKE. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE. 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 11391045 ↗
• MalfunctionJan 8, 2021Component Missing; Component Missing

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11142835 ↗
• InjuryDec 28, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A REVISION SURGERY (REVISION OF A ZIMMER TOTAL KNEE) THE ADAPTER ON THE LGN OFFSET COUPLER TRIAL 4MM DID NOT WORK, IT WILL NOT SCREW ONTO OTHER TRIALS. 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 11077796 ↗
• MalfunctionDec 15, 2020Component Missing; Component Missing

  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 11008194 ↗
• MalfunctionNov 17, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE WHILE OUTSIDE THE BOTTOM CONNECTION PIECE OF THE COUPLER HAS DISCONNECTED, NO HARM TO PATIENT, NOTHING FELL INTO PATIENT, ALL PIECES RECOVERED. NO DELAY REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT IS FRACTURED, WHICH MAKES IT A REPORTABLE EVENT. 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 10852093 ↗
• MalfunctionMar 11, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE SURGEON REPORTED ISSUES WITH COUPLER TRIAL. A S&N BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409249 ↗
• 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 8357777 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE 4MM COUPLER BROKE. NO DELAY REPORTED. NO REVISION SURGERY PERFORMED. BACKUP AVAILABLE. NO INJURY OR IMPACT TO THE PATIENT REPORTED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245969 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE IN TWO DURING SURGERY. THERE WAS NO HARM TO THE PATIENT AND ALL PIECES WERE FOUND AND LOCATED. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242090 ↗

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