GENESIS II 71440001Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00885556033401), received between Jan 22, 2019 and Nov 14, 2024 — classified as 3 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA, THE SCREWS OF TWO (2) GII SPC P/S HOUS COLLET S 3-8 BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683939 ↗
• MalfunctionDec 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA, THE SCREW OF ONE (1) GII SPC P/S HOUS COLLET S 3-8 BROKE UPON IMPACTION OF BOX OSTEOTOME. ALL PIECES WERE REMOVED BY SURGEON HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM. AS PER THE PHOTOS PROVIDED, THE SCREW WAS DETACHED FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18389803 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SPRINGS OF A GII SPC P/S HOUS COLLET S 3-8 POPPED OFF AND THE DEVICE BROKE APART. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH AN UNKNOWN CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262357 ↗
• MalfunctionJun 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY THE REVERSE THREADED BOLT OF THE GII SPC P/S HOUS COLLET S 3-8 CAME APART FROM HOUSING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198709 ↗
• MalfunctionFeb 5, 2023Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA SURGERY, UPON COMPLETION OF THE FEMORAL BOX REAMING, THE BOLT AND SPRING OF THE GII SPC P/S HOUS COLLET S 3-8 DEVICE CAME APART WHILE BEING TAKEN OFF THE TRIAL. ALL COMPONENTS OF THE INSTRUMENT WERE ACCOUNTED FOR, AND NONE WERE LOST OR LEFT IN THE PATIENT INCISION. 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 16302045 ↗
• MalfunctionJan 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER THE SURGEON WAS DISASSEMBLING THE COLLET FROM ONE (1) GII SPC P/S HOUS COLLET S 3-8, THE BOLT, SPRING, AND WASHER FELL APART. THE PROCEDURE WAS ALREADY COMPLETED, SO THERE WAS NO DELAYS. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265423 ↗
• MalfunctionJan 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHEN TIGHTENING ONTO THE TRIAL BLOCK, THE SCREW HEAD ON A GII SPC P/S HOUS COLLET S 3-8 BROKE, CONSEQUENTLY IT WOULD NOT REATTACH TO THE INSTRUMENT. SURGERY WAS RESUMED, WITH AN UNSPECIFIED DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091417 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, (8) LID FOR OUTER CASES, A GII SPC P/S HOUS COLLET S 3-8 AND A GII UNIV PS FEMORAL IMPACTOR WERE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655017 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT ONE OF THE SCREW MECHANISMS OF A GENESIS II SYMMETRICAL POSTERIOR CONDYLES FIXED POSTERIOR STABILIZED HOUSING COLLET SIZE 3-8 BROKE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279800 ↗
• MalfunctionMar 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII SPC P/S HOUS COLLET S 3-8 LOST ITS SPRING. THE SURGICAL TECH WAS UNABLE TO LOCATE THE SPRING. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935744 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE LOCKING KNOB OF A GII SPC P/S HOUS COLLET S 3-8 CAME OUT. AS THIS WAS NOTICED DURING AN INSPECTION THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553123 ↗
• InjuryJan 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII SPC P/S HOUS COLLET S 3-8 BROKE OFF, WHILE INSIDE THE PATIENT. ALL PARTS WERE RECOVERED. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 3 MINUTES DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211082 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II SYMMETRICAL POSTERIOR CONDYLES FIXED POSTERIOR STABILIZED HOUSING COLLET SIZE 3-8 BROKE WHILE BEING REMOVED FROM TRIAL. AS REPORTED, THE INSTRUMENT BROKE WHILE OUTSIDE THE PATIENT. NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005396 ↗
• MalfunctionNov 7, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TKA, A SCREW FROM A GII SPC P/S HOUS COLLET S 3-8 BECAME STUCK IN THE FEMORAL TRIAL, WHICH RESULTED IN PART OF THE SCREW BEING LEFT IN THE LUG HOLE OF THE FEMORAL TRIAL, WHICH CAUSED THE FEMORAL TRAIL UN-USABLE. IT ALSO MADE IT DIFFICULT TO COMPLETE THE ANTERIOR PS BOX REAM ALTHOUGH THIS WAS ACHIEVED THROUGH AN ALTERNATE MEANS. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, HOWEVER; AS THERE WAS NO SPARE FEMORAL TRIAL IN THE SET OR AT THE HOSPITAL, IT WAS NOT POSSIBLE TO COMPLETE THE TRIALING AND SURGEON HAD TO PROGRESS STRAIGHT THE IMPLANTING THE DEFINITIVE IMPLANTS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763522 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE SURGEON WAS REAMING THROUGH THE GII SPC P/S HOUS COLLET S 3-8, THE SPRING CAME FLYING OFF THE HOUSING ALONG WITH THE PEG. THEY TRIED WITH THREE (3) GII SPC P/S HOUS COLLETS S 3-8 AND ALL THREE BROKE OFF. 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 12495257 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE SURGEON WAS REAMING THROUGH THE GII SPC P/S HOUS COLLET S 3-8, THE SPRING CAME FLYING OFF THE HOUSING ALONG WITH THE PEG. THEY TRIED WITH THREE (3) GII SPC P/S HOUS COLLETS S 3-8 AND ALL THREE BROKE OFF. 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 12495150 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE SURGEON WAS REAMING THROUGH THE GII SPC P/S HOUS COLLET S 3-8, THE SPRING CAME FLYING OFF THE HOUSING ALONG WITH THE PEG. THEY TRIED WITH THREE (3) GII SPC P/S HOUS COLLETS S 3-8 AND ALL THREE BROKE OFF. 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 12495090 ↗
• MalfunctionJul 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, AFTER IMPACTING THE PS BOX CHISEL AND GOING TO UNSCREW THE HOLDING SCREW TO READJUST THE GENESIS II SPC P/S HOUS COLLET S 3-8, IT WAS NOTICED THAT SUCH SCREW WAS BROKEN. THE INCIDENT OCCURRED WITH INSTRUMENTS OUTSIDE THE PATIENT; ALL PIECES WERE LOCATED. CASE PROCEEDED WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119182 ↗
• MalfunctionJun 4, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA, USING REAM THROUGH FEMORAL TRIALS. WHILE REAMING THE PS BOX, THE COLLET SCREW JAMMED IN THE FEMORAL TRIAL AND COULD NOT BE REMOVED. THIS MEANS THE SURGEON COULD NOT TRIAL AGAIN AS THE COLLET WAS STILL ATTACHED TO THE FEMORAL TRIAL. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941717 ↗
• MalfunctionMay 10, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII SPC P/S HOUS COLLET S 3-8 WAS NOTICED TO BE LOOSE. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803117 ↗
• InjuryApr 25, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKR SURGERY, THE SCREW FROM A GENESIS II SPC P/S HOUS COLLET S 3-8 THROUGH COLLECT CAME APART AND THE BACK PART GOT STUCK IN THE FEMORAL TRIAL. DUE TO THIS, IT WAS NOT POSSIBLE TO REMOVE THE COLLECT AND WAS NOT ABLE TO TRIAL THE COMPONENTS WITH A 30 MIN OR LESS OF DELAY. THE PROCEDURE WAS COMPLETED WITHOUT TRIALING. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722115 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED THAT THE DURING INSPECTION THE SPRING BROKE OFF. NO CASE INVOLVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319814 ↗
• MalfunctionDec 15, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION THE THREADS OF THE GII SPC P/S HOUS COLLET S 3-8 WERE FOUND STRIPPED. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. 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 11013593 ↗
• MalfunctionDec 10, 2020Break; Break

  IT WAS REPORTED THAT, THE GENESIS II SPC P/S HOUS COLLET S 3-8 BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED. 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 10988524 ↗
• MalfunctionNov 23, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, AFTER PROCEDURE, IT WAS NOTICED THAT THE GII SPC FIXED P/S HOUSING COLLET SZ 3-8 IS UNABLE TO LOCK PROPERLY TO THE CUTTING BLOCK. DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886733 ↗

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