LEGION 71434332Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010549822), received between Feb 26, 2019 and Oct 19, 2022 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, A LGN TIBIAL CUTTING BLOCK RIGHT WAS FOUND TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15630686 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED THAT A LGN TIBIAL CUTTING BLOCK RIGHT WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15630670 ↗
• MalfunctionMay 22, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE LGN TIBIAL CUTTING BLOCK RIGHT WAS FOUND BROKEN. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467105 ↗
• MalfunctionNov 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PIN HOLDING THUMB SCREW OF A LGN TIBIAL CUTTING BLOCK RIGHT BROKE, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748494 ↗
• MalfunctionOct 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS PIN AND DRILL SET BECAME STUCK IN A PIN HOLE OF THE LEGION TIBIAL CUTTING BLOCK RIGHT. THE SURGEON WAS ATTEMPTING TO PRE DRILL HIS FIRST PIN IN ORDER TO PIN THE TIBIAL CUTTING BLOCK IN PLACE, AND THE DRILL CAUGHT IN THE HOLE AND WOULD NOT TURN. THE SURGEON DESCRIBED IT AS SEEMING LIKE THE DRILL WAS TOO BIG FOR THE PIN HOLE. HE WAS ABLE TO REMOVE THE DRILL FROM THE PATIENT¿S TIBIA, WHILE THE DRILL WAS STILL STUCK IN THE CUTTING BLOCK, WITHOUT ANY DIFFICULTY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12574074 ↗
• MalfunctionJun 1, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, A PIN STUCK IN THE LGN TIBIAL CUTTING BLOCK RIGHT. AS THIS WAS NOTICED DURING FIELD INSPECTION, NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916667 ↗
• MalfunctionMay 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A REVISION OF TKA (UNKNOWN IF FROM S+N), A TROCHAR PIN WAS FOUND ATTACHED, PRESUMABLY COLD WELDED, TO A LGN TIBIAL CUTTING BLOCK RIGHT AND CAN'T BE REMOVED. THIS INCIDENT LED TO A SURGICAL DELAY OF FEWER THAN 30 MINUTES, AND IT WAS REPORTED THAT A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849896 ↗
• MalfunctionMar 8, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING TKA SURGERY IT WAS NOTICED THAT A PIN WAS STUCK IN A HOLE OF THE LEGION TIBIAL CUTTING BLOCK RIGHT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431628 ↗
• MalfunctionNov 25, 2020Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE DEVICE BROKE. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT OR NOT. IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF IT WAS DELAYED. PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905823 ↗
• MalfunctionNov 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE SURGEON COLD WELDED PIN IN THE HOLE OF THE CUTTING BLOCK. NO HARM TO THE PATIENT OR DELAY REPORTED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785612 ↗
• MalfunctionOct 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP THE HOLES HAVE BECOME CROSS-THREADED AND PINS ARE CONTINUALLY GETTING STUCK IN THE CUTTING BLOCK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10682668 ↗
• MalfunctionSep 21, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE LEGION TIBIAL CUTTING BLOCK RIGHT TROCAR PINS COLD-WELDED INTO TIBIA CUTTING BLOCK AND UNABLE TO REMOVE DURING SURGERY. SURGERY WAS FINISHED WIT THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564727 ↗
• MalfunctionAug 21, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE LEGION TIBIAL CUTTING BLOCK RIGHT TROCAR PINS COLD-WELDED INTO TIBIA CUTTING BLOCK AND UNABLE TO REMOVE DURING SURGERY. SURGERY WAS FINISHED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10436642 ↗
• MalfunctionMar 4, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE PIN OF A RIGHT LEGION TIBIAL CUTTING BLOCK GOT STUCK IN A PLUS 2MM HOLE AND BROKE OFF. ALL PIECES RECOVERED FROM THE PATIENT. NO HARM TO THE PATIENT OR STAFF. NO SUBSTANTIAL PROCEDURAL DELAY BECAUSE S&N BACK UP WAS AVAILABLE. NO LETTER IS REQUIRED. THE BROKEN DEVICE IS BEING RETURNED TO SMITH & NEPHEW FOR REPLACEMENT VIA FED EX ON (B)(6) 2020.(TRACKING #7778-0586-7360).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788488 ↗
• MalfunctionFeb 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, TROCAR PIN COLD WELDED TO CUTTING BLOCK. SURGEON PULLED THE TIBIA CUTTING BLOCK OFF AND FREE HANDED THE TIBIA CUT. NO DELAY. NO REVISION SURGERY PERFORMED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370814 ↗

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