GENESIS 114943Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 03596010051219), received between Jan 14, 2019 and Sep 2, 2024 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (19 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2024Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A GENESIS CALIPER WAS RUSTY AND ALSO THE NUT FELL OUT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A COMPETITOR DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118395 ↗
• MalfunctionNov 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE THUMBSCREW ON A GENESIS CALIPER BROKE OFF AND FELL ON FLOOR. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864109 ↗
• MalfunctionMar 16, 2022Break; Break

  IT WAS REPORTED THAT THE GENESIS CALIPER WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM HAPPENED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778301 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING SET-UP FOR A TKA SURGERY, THE SCREW OF A GENESIS CALIPER WAS MISSING BECAUSE IT NO LONGER STAYS IN THE GUIDE. AS THIS HAPPENED BEFORE THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549326 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS CALIPERS WAS OBSERVED TO BE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529671 ↗
• MalfunctionFeb 10, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING CLEANING, IT WAS NOTICED THAT THE GENESIS CALIPER WAS FOUND CHIPS AND CRACKS. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506610 ↗
• InjuryFeb 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A GENESIS CALIPER BROKE INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476544 ↗
• MalfunctionFeb 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE THUMB SCREW OF THE GENESIS CALIPER BROKE OFF. NO PIECES FELL INTO PATIENT. DEVICE OUTSIDE 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 13446712 ↗
• MalfunctionJan 5, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT, AFTER A TKA, WAS RETURNED A GENESIS CALIPER AND WAS FOUND MISSING THE HOLDING SCREW. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172212 ↗
• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE THUMB SCREW OF A GENESIS CALIPER BROKE OFF. IT WAS CONFIRMED THAT NO PIECES FELL INTO 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 12874525 ↗
• MalfunctionNov 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SCREW CAME OUT AND WAS LOST IN WASH. CALIPER CAME APART AND PIECE WAS LOST. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868777 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE THUMB SCREW OF A GENESIS CALIPER BROKE OFF AND FELL ON FLOOR. NO PIECES FELL INTO PATIENT. SURGERY WAS FINISHED WITH A S&N BACK UP DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828007 ↗
• MalfunctionOct 5, 2021Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE GENESIS CALIPER WAS BROKEN AND THE SCREW DOES NOT HOLD THE POSITION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576451 ↗
• MalfunctionOct 1, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE GENESIS CALIPER WAS BROKEN AND HAS NO SCREW ON IT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566071 ↗
• MalfunctionSep 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THUMB SCREW OF A GENESIS CALIPER BROKE OFF, NO PIECES 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 12558321 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THUMB SCREW OF A GENESIS CALIPER BROKE OFF, NO PIECES 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 12545005 ↗
• MalfunctionSep 21, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A TKA, IT WAS NOTICED THAT THE NUMBERS ON THE GENESIS CALIPER WERE WORN OFF AND SURGEON COULD NOT READ THEM. 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 12510968 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THUMB SCREW OF A GENESIS CALIPER BROKE OFF. INCIDENT OCCURRED WITH INSTRUMENT OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510952 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A SCREW ON A PATELLA CALIPERS BROKE OFF OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. SURGERY WAS COMPLETED, WITHOUT DELAY, BY USING A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12498021 ↗
• MalfunctionSep 20, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE NUMBERS ON A GENESIS CALIPER ARE WORN OFF AND UNREADABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495656 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GENESIS CALIPER SCREW BROKE OFF AND FELL ON FLOOR. INSTRUMENTS WERE OUTSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135615 ↗
• MalfunctionJul 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, WRITING HAS FADED AND SURGEON CANNOT READ MEASUREMENTS OF THE GENESIS CALIPER. DEVICE OUTSIDE 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 12105174 ↗
• MalfunctionJul 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, WRITING HAD FADED AND SURGEON COULD NOT READ MEASUREMENTS OF THE GENESIS CALIPER. DEVICE OUTSIDE 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 12105150 ↗
• MalfunctionMay 13, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE WRITING ON THE PATELLA CALIPERS HAS WORN OFF AND IS DIFFICULT TO READ. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822687 ↗
• MalfunctionMay 13, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE WRITING ON THE PATELLA CALIPERS HAS WORN OFF AND IS DIFFICULT TO READ. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822633 ↗

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