GENESIS II 71440391Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 03596010453945), received between Feb 26, 2019 and Aug 4, 2025 — classified as 5 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY THE SCREW OF ONE (1) PATELLA RESECTION GUIDE FELL OUT. 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 22710622 ↗
• MalfunctionNov 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA, THE FORCEPS OF A PATELLA RESECTION GUIDE LOOSED THE SCREWS AS SOON AS THE DOCTOR FINISHED SAWING THE PATELLA. THE PINS AND SCREWS FELL INTO THE FIELD. IT IS UNKNOWN IF ALL PIECES WERE RETRIEVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776232 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, A LOCKING PART OF THE IMPACTOR WAS NOTICED ON THE THEATRE FLOOR AS THE SURGEON WAS PREPARING TO CEMENT A FEMORAL COMPONENT INTO THE KNEE AFTER PREPARING THE JOINT. UPON PICKING IT UP AND INSPECTING IT, IT WAS REALIZED THAT IT HAD COME FROM ONE (1) PATELLA RESECTION GUIDE. AFTER ALERTING THE STAFF, THE OTHER PARTS WERE LOCATED ON THE TABLE AND FLOOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353177 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA, THE RIVET SCREW OF ONE (1) PATELLA RESECTION GUIDE WAS FOUND TO BE MISSING WHEN THE INSTRUMENT WAS RETURNED TO TRAY AFTER USE; AS THE HANDLE HAD BECOME LOOSE. AS CONSEQUENCE OF THIS PROBLEM, PATIENT REQUIRED X-RAY TO RULE OUT METAL BEING LOST IN THEIR KNEE. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN, DOING A CHANGE IN SURGICAL TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529391 ↗
• MalfunctionApr 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) ORTHOMATCH MOD PS FEM IMPLANT IMPACTOR BROKE WHEN FIXING THE FEMORAL IMPLANT. AND ONE (1) PATELLA RESECTION GUIDE DISASSEMBLED IN THE DOCTOR'S HAND AFTER CUTTING THE PATELLA. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME IMPACTOR. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197629 ↗
• MalfunctionApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) PATELLA RESECTION GUIDE DISASSEMBLED WHEN USED TO MAKE THE CUT. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142477 ↗
• InjuryApr 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE, A PATELLA RESECTION GUIDE WAS FOUND TO HAVE A MISSING SCREW, THE BACK AS WELL. IT WAS LATER INFORMED THAT THAT MISSING SCREW OR AT LEAST PART OF IT WAS FOUND LEFT IN THE PATIENT JOINT, AS IT WAS CLEARLY VISIBLE ON X-RAYS, THE BACK OF THE SCREW WAS NOT FOUND. DISCUSSED FOLLOW UP PATIENT CARE WITH SURGEON ON THREE SEPARATE OCCASIONS. HE IS NOT INTENDING TO REMOVE THE SCREW, AS PATIENT IS NOT EXPERIENCING ANY DISCOMFORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19057137 ↗
• MalfunctionMar 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TWO FIXING SCREWS OF THE PATELLA RESECTION GUIDE BROKE. SCREWS FELL OUT OF THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. A VISUAL INSPECTION OF THE IMAGE PROVIDED REVEALS THE DETACHMENT OF THE DEVICE COMPONENT. TWO SCREWS OF THE DEVICE ARE DETACH FROM IT, WITHOUT EVIDENT BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620189 ↗
• MalfunctionOct 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATELLA RESECTION GUIDE IS MISSING A SCREW AND NOT WORKING PROPERLY. THIS WAS NOTICED WHILE SETTING UP THE INSTRUMENTS. A REPLACEMENT WAS AVAILABLE TO PROCEED WITHOUT ANY DELAY. THERE WAS NOT ANY IMPACT ON THE USER OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656519 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE SCREW IN THE PATELLA RESECTION GUIDE CLAMP BROKE. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591459 ↗
• MalfunctionSep 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, IN ONE (1) PATELLA RESECTION GUIDE, THE SCREW CAME LOOSE, LOST AND IT MADE THE DEVICE UNUSABLE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358634 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER TKA, BOTH RIVETS ON THE PATELLA RESECTION GUIDE ARE BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241648 ↗
• InjuryJul 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, SURGEON WAS USING THE PATELLA RESECTION GUIDE WITH OSC SAW WHEN THE SCREW VIBRATED OFF OF THE NUT. SURGEON WAS ABLE TO PICKED UP ALL THREE PIECES OF THE WOUND/INCISION. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14933056 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE PIN THAT INDICATES ON THE PATELLA RESECTION GUIDE HAS FALLEN OUT AND NOW DOES NOT FUNCTION PROPERLY. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462353 ↗
• MalfunctionMay 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SCREWS OF THE PATELLA RESECTION GUIDE WERE COMING OUT. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431989 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, A SCREW OF A PATELLA RESECTION GUIDE CAME OUT OF CLAMP. 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 14307734 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SCREW OF A PATELLA RESECTION GUIDE CAME OUT. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140810 ↗
• MalfunctionApr 9, 2022Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW OF A PATELLA RESECTION GUIDE BROKE SO THE DEVICE WILL NOT STAY TOGETHER, ALSO THE SCREW IN THE HANDLE OF A GENESIS CALIPER FELL OUT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICES. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068447 ↗
• MalfunctionApr 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SCREW HAS FALLEN OUT OF JAWS IN A PATELLA RESECTION GUIDE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996174 ↗
• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED THAT A PATELLA RESECTION GUIDE WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791206 ↗
• MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GENESIS II PATELLA RESECTION GUIDE IS DEFECTIVE DUE TO THE LOSS OF A HINGE SCREW. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625013 ↗
• MalfunctionJan 7, 2022Unstable; Unstable

  IT WAS REPORTED THAT A PATELLA RESECTION GUIDE IS LOOSE. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191920 ↗
• MalfunctionJan 4, 2022Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE PATELLA RESECTION GUIDE WAS BROKEN AND IT IS MISSING ONE OF THE THREADED NUTS THAT HOLDS IT TOGETHER. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13159328 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PATELLA RESECTION GUIDE BROKE WHILE OUTSIDE 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 12811705 ↗
• InjuryNov 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A SCREW CAME OUT THE OF RIGHT SIDE OF A PATELLA RESECTION GUIDE, WHILE INSIDE THE PATIENT. ALL PIECES WERE SUCCESSFULLY RETRIEVED. SURGERY WAS COMPLETED WITH A BACK UP DEVICE. NO DELAY. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790517 ↗

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