GENESIS II 71440145Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 03596010471338), received between May 18, 2020 and Apr 10, 2024 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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. 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON WAS REAMING THE PS BOX ON A GENESIS II KNEE WHEN THE GII P/S CONS HOUSING REAM DOME SNAPPED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076962 ↗
• MalfunctionNov 7, 2023Fracture; Difficult or Delayed Separation; Fracture; Difficult or Delayed Separation

  IT WAS REPORTED THAT, DURING A TKA, BOTH GII P/S CONS HOUSING REAM DOME AND A GII PATELLAR REAMER SHAFT GOT STUCK TOGETHER, AS CONSEQUENCE THE GII P/S CONS HOUSING REAM DOME BROKE OFF. NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, IMPLANTING A CR (CRUCIATE RETAINING) GEN II SYSTEM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083290 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT, ONE GII P/S CONS HOUSING REAM DOME WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126500 ↗
• MalfunctionMay 23, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14478787 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14478752 ↗
• MalfunctionMay 23, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE GII P/S CONS HOUSING REAM DOME 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 14470584 ↗
• MalfunctionMay 23, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14470292 ↗
• MalfunctionMay 22, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14467111 ↗
• MalfunctionMay 22, 2022Break; Break

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14467110 ↗
• MalfunctionMay 22, 2022Break; Break

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14467108 ↗
• MalfunctionMay 22, 2022Break; Break

  IT WAS REPORTED THAT, A GII P/S CONS HOUSING REAM DOME 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 14467107 ↗
• MalfunctionMay 22, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, THE GII P/S CONS HOUSING REAM DOME WAS FOUND TO BE BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467106 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, A GII P/S CONS HOUSING REAM DOME WAS MISSING THE METAL PEGS TO LOCK ONTO REAMER, AND THE SHAFT WORN DOWN THE REAMER, THEREFORE, THE SHAFT DISENGAGED. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455085 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE MIDDLE PIECE OF A GII P/S CONS HOUSING REAM DOME WAS FOUND BROKEN WHEN THE INSTRUMENT WAS REMOVED FROM THE TRAY. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14225763 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT, THE GII P/S CONS HOUSING REAM DOME WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 13110340 ↗
• MalfunctionApr 23, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A GII P/S CONS HOUSING REAM DOME 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 11716329 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT, BEFORE A TKA PROCEDURE, A REAMER HAD A CRACK IN TOP OF IT AND NEEDS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566386 ↗
• InjuryFeb 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE THREE GII P/S CONS HOUSING REAM DOMES WERE FOUND WORN AND NOT CUTTING THROUGH BONE ANYMORE. THERE WAS A CHANGE IN TECHNIQUE DUE TO THIS MALFUNCTION. A DELAY OF LESS THAN 30 MIN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357025 ↗
• InjuryFeb 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE THREE GII P/S CONS HOUSING REAM DOMES WERE FOUND WORN AND NOT CUTTING THROUGH BONE ANYMORE. THERE WAS A CHANGE IN TECHNIQUE DUE TO THIS MALFUNCTION. A DELAY OF LESS THAN 30 MIN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357022 ↗
• InjuryFeb 22, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE THREE GII P/S CONS HOUSING REAM DOMES WERE FOUND WORN AND NOT CUTTING THROUGH BONE ANYMORE. THERE WAS A CHANGE IN TECHNIQUE DUE TO THIS MALFUNCTION. A DELAY OF LESS THAN 30 MIN WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357016 ↗
• MalfunctionJul 19, 2020Degraded; Degraded

  IT WAS REPORTED THAT THE REAMER DOME WAS FOUND WORN OUT. THERE WAS NO DELAY NOR INJURY REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10293709 ↗
• MalfunctionJul 15, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING TKA PROCEDURE WITH INSTRUMENT INSIDE THE PATIENT, THE GII P/S CONS HOUSING REAM DOME WAS FOUND TO BE WORN OUT. NO DELAY. PROCEDURE WAS FINISHED USING A S&N BACK UP DEVICE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10274513 ↗
• MalfunctionJul 9, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE REAMER HAS BECOME DULL DUE TO WEAR AND TEAR OF USE. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10254802 ↗
• MalfunctionJul 9, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE REAMER HAS BECOME DULL DUE TO WEAR AND TEAR OF USE. NO CASE INVOLVED. 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 10254708 ↗
• MalfunctionJul 8, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE REAMER HAS BECOME DULL DUE TO WEAR AND TEAR OF USE. NO CASE INVOLVED. 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 10248513 ↗

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