GENESIS II 71440324Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010214997), received between Jan 21, 2019 and Aug 26, 2025 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) GII PATELLAR REAMER SHAFT BROKE. THE LOCKING COLLAR BROKE ON IT, THEREFORE, THERE WERE NO LOOSE PIECES. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900895 ↗
• MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE SILVER RING OF A GII PATELLAR REAMER SHAFT DISASSOCIATED DURING BCS FEMORAL REAMING. IT IS UNKNOWN HOW PROCEDURE WAS RESUMED, BUT IT WAS COMPLETED WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969807 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA PROCEDURE, THE GII PATELLAR REAMER SHAFT AND JOURNEY FEM IMPACT BUMPER LT WERE WORN AND BROKE. AS THIS WAS NOTICED BEFORE PROCEDURE, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283170 ↗
• MalfunctionApr 6, 2022Break; Break

  IT WAS REPORTED THAT, THE TIP OF A GII PATELLAR REAMER SHAFT IS BROKEN. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT, THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018549 ↗
• MalfunctionMar 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GII PATELLAR REAMER SHAFT IS MISSING A SCREW ON THE HEAD. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710883 ↗
• MalfunctionDec 27, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE RING AROUND THE GOLD BUTTON OF THE GII PATELLAR REAMER SHAFT WAS NO LONGER ATTACHED. 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 13090815 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY A GII PATELLAR REAMER SHAFT WAS BROKEN. INSTRUMENTS WERE OUTSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, SURGERY WAS DONE WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782906 ↗
• MalfunctionOct 5, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, THE PRIMARY RING OF A GII PATELLAR REAMER SHAFT HAD BEEN DISCONNECTED FROM THE THREADING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576390 ↗
• InjuryJun 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIECE OF THE GII PATELLAR REAMER SHAFT BROKE WHILE REAMING THE BOX OF THE FEMUR. 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 11953421 ↗
• MalfunctionMay 20, 2021Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SPRING MECHANISM OF A BRAND NEW GII PATELLAR REAMER SHAFT DID NOT WORK, THE PHYSICIAN HAD DIFFICULTY REMOVING REAMER. THE PROCEDURE WAS FINISHED WITH THE SAME FAULTY DEVICE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860172 ↗
• MalfunctionMay 20, 2021Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SPRING MECHANISM OF A BRAND NEW GII PATELLAR REAMER SHAFT DID NOT WORK, THE PHYSICIAN HAD DIFFICULTY REMOVING REAMER. THE PROCEDURE WAS FINISHED WITH THE SAME FAULTY DEVICE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860171 ↗
• MalfunctionMay 20, 2021Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SPRING MECHANISM OF A BRAND NEW GII PATELLAR REAMER SHAFT DID NOT WORK, THE PHYSICIAN HAD DIFFICULTY REMOVING REAMER. THE PROCEDURE WAS FINISHED WITH THE SAME FAULTY DEVICE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860167 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A GII PATELLAR REAMER SHAFT BROKE. 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 11853644 ↗
• InjuryMay 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, THE PIN OF THE GII A/R FEM SIZING GUIDE COULD NOT FIT THRU THE SIZING GUIDE ((B)(4)). A GII QUICK CONNECT HANDLE COULD NOT STAY ENGAGED IN BLOCK ((B)(4)). A GII UNIV PS FEMORAL IMPACTOR BROKE WHILE ENGAGING ((B)(4)). THE RING OF THE GII PATELLAR REAMER SHAFT WAS DISLODGED/CAME OFF, NOT SEALED PROPERLY ((B)(4)). INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805791 ↗
• MalfunctionApr 23, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A GENESIS II PATELLAR REAMER SHAFT DID NOT STAY CONNECTED. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF IT WAS DELAYED, THEREFORE, PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716324 ↗
• MalfunctionApr 14, 2021Break; Break

  IT WAS REPORTED, THAT DURING INSPECTION THE THREADS ON GII PATELLAR REAMER SHAF IS CHIPPED CAUSING IT TO FAIL INSPECTIO. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667926 ↗
• MalfunctionApr 1, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SET UP INSPECTION PROCESS, THE GII PATELLAR REAMER SHAFT DID NOT LOCK IN. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE, AND NO SURGICAL DELAY NOR INJURY TO PATIENT OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605385 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE SCREW FROM THE TIBIA CUT BLOCK SNAPPED OFF THE BLOCK AS THE DOCTOR WAS TIGHTENING THE SCREW ON THE ROD FROM THE TIBIA JIG. ((B)(4)) ALSO REPORTED ANOTHER INSTRUMENT MALFUNCTION WITH THIS CASE, THE REAMER SHAFT HAD A BROKEN RING ON IT THAT WOULD NOT ALLOW IT TO LOCK ON TO THE ACTUAL REAMER. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326446 ↗
• MalfunctionOct 15, 2020Break; Break

  IT WAS REPORTED THAT THE TIP OF THE REAMER SHAFT BROKE. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10683396 ↗
• MalfunctionAug 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING INSPECTION IT WAS FOUND THAT THE CUTTER HANDLE DOES NOT FIX THE CUTTER BASKETS. THE TIBIAL CUTTING BLOCKS LEFT AND RIGHT DO NOT FIT ON THE EXTRAMED. ALSO, THE TIBIAL ALIGNMENT RODS. THIS WAS NOTED DURING INSPECTION

  Patient problems: No Patient Involvement

  MAUDE report 10445404 ↗
• MalfunctionAug 5, 2020Break; Break

  IT WAS REPORTED THAT BEFORE A PROCEDURE THE SURGEON STATED THAT THE GENESIS II PATELLAR REAMERS SHAFT BROKE. ALL PIECES WERE RECOVERED. A S+N BACKUP DEVICE WAS AVAILABLE. NO PATIENT HARM OR DELAY WAS REPORTED.

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

  MAUDE report 10371268 ↗
• MalfunctionJun 18, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS WEAR AND TEAR. THERE IS NOT A PATIENT INVOLVED IN THE CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10171436 ↗
• MalfunctionMar 9, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE BOTTOM OF THE REAMER SHAFT BROKE OFF. ALL PIECES WERE RECOVERED DURING SURGERY AND THERE WAS NO HARM TO THE PATIENT. NO DELAY TO THE PATIENT BECAUSE A S&N BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805997 ↗
• InjuryApr 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING SURGERY PERFORMING INLAY PATELLA REAMING AND THE DEPTH STOP SLIPPED. THIS CAUSED OVER REAMING OF THE PATELLA. HE WAS ABLE TO BONE GRAFT THE DEFECT AND THEN CEMENT THE IMPLANT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES TO PREPARE AND GRAFT THE DEFECT. WE NEED TO WAIT TO SEE IF ANY ISSUE OCCURRED AS THE PATIENT RECUPERATES.

  Patient problems: Injury

  MAUDE report 8489942 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THEY WERE REAMING THE FEMUR BOX FOR A PS FEMUR AND WHEN THEY GOT DONE REAMING WE NOTICED THE POINTED END OF THE REAMER SHAFT HAD BROKEN OFF. NO DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8265275 ↗

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