GENESIS II 71441154Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010497222), received between Jul 29, 2019 and Jun 17, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SPIKE ON THE BACK OF ONE (1) GII MIS DCF AP CT BLK 6 BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537800 ↗
• MalfunctionMay 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PEGS OF THE GII MIS DCF AP CT BLK 6 BROKE OFF WHILE IMPACTING BLOCK. ALL PIECES WERE REMOVED FROM PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22119622 ↗
• MalfunctionMay 29, 2025Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE MALLET IMPACT BROKE OFF THE FIXATION SPIKE OF ONE (1) GII MIS DCF AP CT BLK 6. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 22106522 ↗
• MalfunctionJan 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE IMPACTING, THE SPIKE OF THE GII MIS DCF AP CT BLK 6 BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 21274070 ↗
• MalfunctionJan 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SPIKE OF ONE (1) GII MIS DCF AP CT BLK 6 FRACTURED UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO PIECES FELL INTO THE PATIENT. THERE WAS NO SURGICAL DELAY OR INJURIES REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163854 ↗
• MalfunctionSep 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) GII MIS DCF AP CT BLK 6 BROKE OFF IN FEMORAL ANATOMY DURING NORMAL USE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118204 ↗
• MalfunctionJun 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHEN REMOVING THE GII MIS DCF AP CT BLK 6, ONE OF THE FIXATION SPIKES BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486127 ↗
• MalfunctionApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE IMPACTING ONE (1) GII MIS DCF AP CT BLK 6, ONE OF ITS PINS BROKE. THE BROKEN PIN WAS RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053369 ↗
• MalfunctionApr 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE OF THE SPIKES ON BACK OF THE GII MIS DCF AP CT BLK BROKE OFF. 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 16825884 ↗
• MalfunctionJan 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII MIS DCF AP CT BLK 6 BROKE INTO TWO PIECES. IT HAPPENED WHEN THE SURGEON REMOVED IT FROM BONE AFTER USING IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268141 ↗
• InjuryDec 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SPIKE ON THE BACK OF THE GII MIS DCF AP CT BLK 6 DEVICE BROKE OFF INTO PATIENT AND WAS RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH 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 15921679 ↗
• MalfunctionOct 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT A GII MIS DCF AP CT BLK 6 IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15578018 ↗
• InjurySep 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA PROCEDURE, THE SPIKE ON BACK OF THE GII MIS DCF AP CT BLK 6 BROKE OFF INTO FEMUR. THE SPIKE WAS LEFT INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15399847 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THAT THE GII MIS DCF AP CT BLK 6 BROKE OFF FROM HITTING WITH MALLET 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 13691429 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A GENESIS II MINIMALLY INVASIVE DISTAL CUT FIRST ANTERIOR POSTERIOR CUTTING BLOCK SIZE 6 DISTAL PEG IS NO LONGER ATTACHED. NO CASE INVOLVED, THEREFORE NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477950 ↗
• MalfunctionMar 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, COMPONENT ARE UNFIT FOR USE. THE GII MIS DCF AP CT BLK 3 HAVE BURRS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586446 ↗
• MalfunctionFeb 23, 2021Crack; Crack

  IT WAS REPORTED THAT THE CHAMFER OF CUTTING BLOCK CRACKED AT SLAPHAMMER ATTACHMENT POINT. 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 11364943 ↗
• MalfunctionOct 22, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SPIKE OF THE GII MIS DCF AP CT BLK 6 HAS DEVELOPED AN ANGLE FROM WEAR AND TEAR. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10721931 ↗
• MalfunctionSep 20, 2020Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE THE SIZE 6 FEMORAL CUT BLOCK PEG WAS FOUND BROKEN. NO DELAY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10558291 ↗
• MalfunctionSep 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE GII MIS DCF AP CT BLK 6 IS WORN FROM EXCESSIVE USE. THERE WAS NO CASE INVOLVED. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10518437 ↗
• InjuryJun 19, 2020Break; Component Missing; Separation Failure; Break; Component Missing; Separation Failure

  IT WAS REPORTED THAT AFTER PROCEDURE TKA THE SURGEON DID NOT NOTICE THE MISSING PEG FROM THE CUTTING BLOCK UNTIL POSTOPERATIVE X-RAY (DURING THE PROCEDURE THE SURGEON FOLLOWED PROPER TECHNIQUE IN PLACEMENT AND REMOVAL OF THE 4 IN 1 CUTTING BLOCK). THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

  Patient problems: Injury

  MAUDE report 10176766 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT THERE IS A BROKEN LEGION CUTTING BLOCK. IT BROKE INSIDE OF THE BONE OF A PATIENT. NO INJURIES OR DELAYS REPORTED. S+N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370105 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, PEG BROKE INSIDE PATIENT. SURGEON WAS ABLE TO EXTRACT IT WITH TWEESERS. USED A SECOND INSTRUMENT TO RESUME SURGERY. DELAY FROM 30 MINUTES TO 1 HOUR REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839757 ↗

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