GENESIS II 71440820Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010407351), received between Jun 5, 2019 and Dec 19, 2024 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII POST REF A/P BLK SZ 6 DAMAGED. THE BROKEN PIN WAS REMOVED FROM THE BONE USING BONE NIBBLERS. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976656 ↗
• MalfunctionNov 27, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TKR SURGERY, A PIN OF A GII POST REF A/P BLK SZ 6 WAS MISSING, REMAINING IN THE FEMUR OF THE PATIENT. SURGEON USED A BONE NIBBLER TO GRASP AND REMOVE THE PIN. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209875 ↗
• MalfunctionOct 9, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, SURGEON WAS PERFORMING A GENII TKR AND WHEN REMOVING ONE (1) GII POST REF A/P BLK SZ 6, IT WAS NOTICED THAT THE PIN WAS REMAINING IN THE PATIENT. HE WAS ABLE TO RETRIEVE THE PIN WITH A BONE CUTTER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901792 ↗
• MalfunctionJul 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE IMPACTING THE GII POST REF A/P BLK SZ 6 ONTO THE PATIENT'S BONE, THE PIN OF THE GII POST REF A/P BLK SZ 6 SNAPPED. ALL PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289619 ↗
• MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN OF A GII POST REF A/P BLK SZ 6 BECAME LOOSE FROM THE MAIN DEVICE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136401 ↗
• MalfunctionFeb 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE PIN IN ONE (1) GII POST REF A/P BLK SZ 6 BROKE OFF. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, 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 16302069 ↗
• MalfunctionApr 23, 2022Break; Break

  IT WAS REPORTED THAT THE PIN IN THE BACK OF BLOCK ON THE GII POST REF A/P BLK SZ 6 BROKE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191042 ↗
• MalfunctionMar 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE OF THE SPIKES ON BACK OF A GII POST REF A/P BLK SZ 6 BROKE OFF. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866640 ↗
• InjuryMar 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMORAL STABILISING SPIKE OF A GII POST REF A/P BLK SZ 6 SHEARED OFF AND WAS RETAINED IN THE FEMUR. IT IS UNKNOWN IF THE SPIKE WAS RETRIEVED FROM THE PATIENT. IT IS ALSO UNKNOWN HOW PROCEDURE WAS COMPLETED AND IF IT WAS DELAYED AS CONSEQUENCE OF THE PRODUCT FAILURE. PATIENT CURRENT HEALTH STATUS IS ALSO UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838090 ↗
• InjuryMar 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMORAL STABILISING SPIKE OF A GII POST REF A/P BLK SZ 6 SHEARED OFF AND WAS RETAINED IN THE FEMUR. IT IS UNKNOWN IF THE SPIKE WAS RETRIEVED FROM THE PATIENT. IT IS ALSO UNKNOWN HOW PROCEDURE WAS COMPLETED AND IF IT WAS DELAYED AS CONSEQUENCE OF THE PRODUCT FAILURE. PATIENT CURRENT HEALTH STATUS IS ALSO UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13816784 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT, WHILE INSPECTION FOLLOWING CLEANING, IT WAS NOTICED THAT A PIN WAS BREAKING OFF THE BACK OF THE GII POST REF A/P BLK SZ 6. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697225 ↗
• InjuryFeb 22, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BONE SPIKE ON THE BACK OF A GII POST REF A/P BLK SZ 6 SHEARED OFF WHILE IMPACTING. ALL BROKEN PIECES WERE RETRIEVED FROM THE WOUND. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581145 ↗
• MalfunctionFeb 9, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II POSTERIOR REFERENCING ANTERIOR/ POSTERIOR CUTTING BLOCK SIZE 6 CRACKED AND BROKE WHILST BEING IMPACTED ON TO THE FEMUR BY THE SURGEON. NO PIECES FELL INSIDE OF 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 13499692 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, THE SPIKE OF A GENESIS II POSTERIOR REFERENCING ANTERIOR/POSTERIOR CUTTING BLOCK SIZE 6 BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442795 ↗
• InjuryDec 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII POST REF A/P BLK SZ 6 BROKE OFF, ALL PIECES WERE RETRIEVED. DEVICE INSIDE 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 13025077 ↗
• MalfunctionAug 10, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT A PIN FROM THE BACK OF GII POST REF A/P BLK SZ 6 HAS BROKEN OFF. THIS INSTRUMENT HAS HAD SIGNIFICANT USE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303586 ↗
• MalfunctionMay 21, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SET UP FOR TKA, IT WAS FOUND THAT A SPIKE FROM THE GII POST REF A/P BLK SZ 6 WAS MISSING. IT IS SUSPECTED THAT THE DEVICE GOT STUCK IN A HOLE AT THE BOTTOM OF THE TRAY CAUSING THE SPIKE TO DETACHED. NO SURGICAL DELAY WAS REPORTED, IT IS UNKNOWN IF THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE OR A REPLACEMENT ONE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863496 ↗
• MalfunctionMar 29, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE GENESIS II POST REFLECTION A/P BLK SIZE 6 WAS NOTICED DAMAGED DUE TO WEAR AND TEAR. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586749 ↗
• InjuryMar 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA ONE OF THE SPIKES HAS BROKEN OFF THE BACK OF THE GII POST REF A/P BLK SZ 6. THIS OCCURRED WHEN IMPACTING THE BLOCK INTO THE FEMUR. THE BROKEN SPIKE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548670 ↗
• InjuryFeb 28, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA WHEN THE SURGEON WAS IMPACTING THE GII POST REF A/P BLK SZ 6 ONTO THE FEMUR THE PINS ON THE BACK OF THE BLOCK BROKE OFF, INSTRUMENTS INSIDE PATIENT. A SECOND BLOCK WAS AVAILABLE TO FINISH THE CASE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. 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 11391044 ↗
• InjuryFeb 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING THE TKA PROCEDURE THAT THE PIN ON THE BACK OF THE CUTTING BLOCK WAS BROKEN AND DETACHED INSIDE THE PATIENT, BUT THE SURGEON REMOVED IT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326552 ↗
• InjuryOct 21, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE INSIDE THE PATIENT, THE CUTTING BLOCK HAD A PIN BROKEN OFF OF IT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND PROCEDURE CONTINUED WITH THE SAME DEVICE, WITH A DELAY OF LESS THAN 30 MINUTES AND WITHOUT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10712243 ↗
• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT IN A PRIMARY GENESISII TKR PROCEDURE ON A RIGHT KNEE WHILE REMOVING THE POST REF A/P FEMORAL CUTTING BLOCK THE SECURING PINS FRACTURED AND REMAINED IN THE FEMUR. IT TOOK THE SURGEON APPROXIMATELY 15MINS TO REMOVE THEM, HE WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENT. THE DEFECTIVE INSTRUMENT IS BEING CLEANED FOR COLLECTION AND INSPECTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10653029 ↗
• MalfunctionSep 18, 2020Misassembled; Misassembled

  IT WAS REPORTED THAT DURING SURGERY WHILE IMPACTING INSIDE THE PATIENT, THE DEVICE SLIPPED THROUGH AND FELL INTO THE DRAPES. THERE WAS A DELAY BELOW 30 MINUTES REPORTED AND NO INJURY WAS REPORTED. A S&N BACKUP DEVICE WAS AVAILABLE TO FINISHED THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10552210 ↗
• MalfunctionJun 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SPIKE IN BACK BROKE OFF AS THE SURGEON WAS REMOVING THE 4 INCH BLOCK. NOTHING FELL INTO PATIENT. NO HARM TO PATIENT OR STAFF. NO PROCEDURAL DELAYS. SMITH & NEPHEW BACK UP WAS AVAILABLE IF NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672700 ↗

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