GENESIS II 71440842Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 03596010485045), received between Feb 11, 2019 and Jun 11, 2024 — classified as 113 malfunctions.

The most frequently reported specific device problem is “Break” (102 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY WHILE SIZING THE PATELLA, ONE (1) GII OVAL PATELLA {} 5 PT. SZ GDE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510525 ↗
• MalfunctionJun 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GII OVAL PATELLA {} 5 PT. SZ GDE BROKE WHEN TRICKLING THE PATELLA. NO X-RAY AVAILABLE, PART RETRIEVED WITH SUCTION. 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 19442267 ↗
• MalfunctionMar 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE OF THE SIZERS GII OVAL PATELLA {} 5 PT. SZ GDE BROKE OFF. NOTHING FELL INTO THE PATIENT. ALL PIECES RETRIEVED BY HAND. 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 18858385 ↗
• MalfunctionSep 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, A PIECE OF ONE (1) GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675164 ↗
• MalfunctionApr 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE ARM OF THE GII OVAL PATELLA 5 PT. SZ GDE DEVICE BROKE. NO BROKEN PIECE FELL INTO THE WOUND. THE PROCEDURE WAS PERFORMED, 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 16690351 ↗
• MalfunctionSep 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A GII OVAL PATELLA {} 5 PT. SZ GDE WAS FOUND TO BE BROKEN DUE TO MANY YEARS OF USE. SURGERY WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACKUP DEVICE. THE PATIENT WAS NOT INJURED BEYOND THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384047 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14611434 ↗
• MalfunctionMay 14, 2022Break; Break

  IT WAS REPORTED THAT THE GII OVAL PATELLA {} 5 PT. SZ GDE 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 14403187 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT A GII OVAL PATELLA {} 5 PT. SZ GDE BROKE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307659 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, THREE (3) GII OVAL PATELLA 5 PT. SZ GDE ARE MISSING A SIZE THAT WAS BROKEN OFF. EACH SIZING GUIDE IS MISSING ONE SIZE. AS THIS WAS NOTICE DURING FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279552 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, THREE (3) GII OVAL PATELLA 5 PT. SZ GDE ARE MISSING A SIZE THAT WAS BROKEN OFF. EACH SIZING GUIDE IS MISSING ONE SIZE. AS THIS WAS NOTICE DURING FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272448 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT A GII OVAL PATELLA 5 PT. SZ GDE IS BROKEN. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003483 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983108 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF FROM TOO MUCH USE. AS THIS HAPPENED AFTER A TKA SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935050 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF FROM TOO MUCH USE. AS THIS HAPPENED AFTER A TKA SURGERY THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934963 ↗
• MalfunctionMar 23, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, IT WAS FOUND THAT A GII OVAL PATELLA 5 PT. SZ GDE SIZER WAS CRACKED. THE PROCEDURE WAS ABLE TO BE COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870364 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, THE GII OVAL PATELLA 5 PT. SZ GDE WAS FOUND BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715571 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF. AS THIS HAPPENED DURING THE SET UP OF A TKA SURGERY, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697833 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT ONE ARM OF THE GENESIS II OVAL PATELLA 5 PT. SIZE GDE HAD BROKEN OFF. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691570 ↗
• MalfunctionFeb 27, 2022Break; Break

  IT WAS REPORTED THAT A GII OVAL PATELLA 5 PT. SZ GDE BROKE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615240 ↗
• MalfunctionFeb 27, 2022Break; Break

  IT WAS REPORTED THAT A GII OVAL PATELLA 5 PT. SZ GDE BROKE. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615237 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT, A GII OVAL PATELLA 5 PT. SZ GDE WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595804 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT WHILE OPENING THE GII OVAL PATELLA 5 PT. SZ GDE FOR THE TKA, THE ITEM WAS NOTICED TO HAVE A SECTION BROKEN OFF OF IT (DURING WASHING/ STERILIZING.) NO CASE WAS INVOLVED, THERE WAS A S&N BACK UP AVAILABLE, AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581067 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR TKA, ONE OF THE GII OVAL PATELLA 5 PT. SZ GDE BROKE OFF. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. AS THIS WAS NOTICED DURING SET UP, NO INJURY TO PATIENT OR DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540147 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT THE GII OVAL PATELLA SIZING GUIDE IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509478 ↗

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