GENESIS II 71441155Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010497239), received between Apr 8, 2020 and May 31, 2026 — classified as 3 injuries, 10 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, THE PRONG OF ONE (1) GII MIS DCF AP CT BLK 7 BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344157 ↗
• MalfunctionFeb 11, 2026Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SURGEON PLACED ONE (1) GII MIS DCF AP CT BLK 7 ON THE DISTAL FEMUR TO PREPARE THE 4-IN-1 CUT. PRIOR TO PERFORMING THE CUT, THE BLOCK WAS NOTED TO BE UNSECURED. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE FIXATION SPIKE ON THE POSTERIOR SIDE OF THE BLOCK HAD BROKEN OFF AND REMAINED EMBEDDED IN THE PATIENT'S BONE. THE BLOCK WAS THEN REALIGNED AND PINNED IN POSITION TO COMPLETE THE PLANNED CUTS. THE SURGEON SECURED THE CUT BLOCK IN THE APPROPRIATE POSITION TO COMPLETE THAT PORTION OF THE TECHNIQUE. A TREPHINE WAS SUBSEQUENTLY USED TO REMOVE THE BROKEN SPIKE FROM THE BONE. THE INCIDENT RESULTED IN AN ADDITIONAL 5¿10 MINUTES OF SURGICAL TIME. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT 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 24312339 ↗
• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE POST OF THE GII MIS DCF AP CT BLK 7, BROKE OFF. ALL PARTS OF THE ITEM WERE ACCOUNTED FOR AND SURGEON AWARE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895165 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS II MINAMALLY INVASIVE DISTAL CUT FIRST ANTERIOR POSTERIOR CUTTING BLOCK SIZE 7 BROKE. IT IS UNKNOWN IF THE DEVICE BROKE WHILE INSIDE OR WHILE OUTSIDE THE PATIENT. IT IS ALSO UNKNOWN IF ANY PIECE FELL INSIDE 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 12820298 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, POST OF THE GENESIS II MIS DCF AP CT BLK 7 WAS BROKEN OFF UPON REMOVAL OF THE BLOCK. ALL PIECES RECOVERED (OUTSIDE THE PATIENT). THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849678 ↗
• InjuryApr 27, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA THE GENESIS II MIS DCF AP CT BLK 7 POSTERIOR AND ANTERIOR CHAMBER CAPTURE BROKE. THIS HAPPENED WHEN THE DEVICE WAS INSIDE THE PATIENT. BUT THIS DID NOT CAUSE ANY INJURY TO THE PERSON. NO SIGNIFICANT DELAY HAPPENED DURING THE PROCESS AND THE SAME DEVICE FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730244 ↗
• MalfunctionApr 15, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE GENESIS II MIS DCF AP CT BLK FROM SIZE 3 TO 8 ARE HAVING ISSUES FITTING. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. AFTER PRODUCT EVALUATION IT WAS DETERMINED THAT THE DEVICE IS HEAVILY WORN WITH MANY NICKS, SCRATCHES, AND BURRS AROUND THE CUTTING SLOTS. 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 11676324 ↗
• 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 11586543 ↗
• InjuryFeb 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY THE PEG ON THE GENESIS II MIS DCF AP CT BLK 7 BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED WITH A TREPHINE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MINS. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340606 ↗
• InjuryOct 28, 2020Break; Break

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY UPON IMPACTION OF INSTRUMENT IN PATIENT, POSTERIOR SPIKE BROKE OFF. THE PIECE WAS REMOVED BY A CHISEL AND RONGEUR TO GOUGE OUT A SMALL AREA AROUND THE RETAINED PIECE AND IT WAS THEN REMOVED WITH A HEAVY NEEDLE DRIVER. THERE WAS A DELAY OF 10 MINUTES. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10748935 ↗
• MalfunctionSep 17, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CHAMFER OF CUTTING BLOCK BROKE OFF OF. NO CASE INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10546555 ↗
• MalfunctionSep 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE GII MIS DCF AP CT BLK 7 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 10518597 ↗
• MalfunctionApr 8, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, DEVICE BROKE DURING SURGERY. DELAY OF ZERO TO THIRTY MINUTES REPORTED. BACKUP DEVICE AVAILABLE. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9940967 ↗

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