GENESIS II 71433346Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556032107), received between Jun 2, 2020 and Sep 5, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A ROUTINE PRIMARY LEGION TKA, AFTER TRIALING WITH A GENESIS II SYMMETRICAL POSTERIOR CONDYLES REAM THROUGH CRUCIATE RETAINING TRIAL SIZE 6 LEFT AND TAKING THE KNEE AN EXTENSION-FLEXION RANGE THERE APPEARED TO BE A PIECE OF CARTILAGE TRAPPED IN THE LATERAL HOLE OF THE FEMORAL TRIAL COMPONENT THAT IS UTILIZED TO PREPARE CR LUNGS. ON INSPECTION IT WAS NOTED THAT THE PREVIOUSLY VERY HEALTHY PATELLA HAD A DEFECT IN IT THAT MATCHED THIS PIECE OF CARTILAGE. FURTHERMORE, THE SURGEON BELIEVES THAT THE HOLE HAD ESSENTIALLY ACTED AS A CHEESE GRATER IN REMOVING THIS PIECE OF CARTILAGE ON THE PATELLA DURING A TRIAL RANGE OF MOTION. THE SURGEON INSPECTED THE FEMORAL TRIAL AND COULD NOT IDENTIFY A HIGH POINT. THE SURGEON HAS REQUESTED TO CLOSELY INSPECT THE TRIAL FOR ANY DEFECT THAT COULD HAVE LED TO THE INJURY AND SUGGESTED THAT THE TRIAL LUG HOLES SHOULD BE CHANGED IN DESIGN TO AVOID THIS. AT THIS MOMENT IT REMAINS UNCLEAR IF THERE WAS A DELAY AND HOW THE SURGERY WAS COMPLETED. THE PATIENTS CURRENT HEALTH STATUS REMAINS UNCLEAR.

  Patient problems: Cartilage damage

  MAUDE report 17684497 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT, AFTER A TKA, DURING EQUIPMENT STERILIZATION, A GII SPC REAMTHRU CR TR SZ 6 LT WAS NOTICED TO HAVE A SMALL CRACK IN THE BACK SIDE. AS THIS WAS NOTICED AFTER PROCEDURE, THE SURGERY HAD BEEN COMPLETED WITHOUT ANY SURGICAL DELAY, WITH SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201261 ↗
• MalfunctionMay 13, 2021Crack; Crack

  IT WAS REPORTED THAT, BEFORE A TKA, A GII SPC REAMTHRU CR TR SZ 6 LT WAS NOTICED TO BE CRACKED. 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 11817296 ↗
• MalfunctionMay 10, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION A GII SPC REAMTHRU CR TR SZ 6 LT (CASE: (B)(4)) AND A GII SPC REAMTHRU CR TR SZ 7 RT (CASE: (B)(4)) WERE FOUND CRACKED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803272 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY IT WAS NOTICED THAT THE METAL IS BREAKING AROUND THE NOTCH ON THE GII SPC REAMTHRU CR TR SZ 6 LT. INCIDENT OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566388 ↗
• MalfunctionJan 14, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT A GENESIS II SPC REAMTHRU CR TR SIZE 6 LEFT IS WEARN. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168685 ↗
• MalfunctionNov 4, 2020Crack; Crack

  IT WAS REPORTED THAT, WHILE INSPECTING INSTRUMENTS, A SLIGHT CRACK WAS NOTICED IN THE TRIALS. NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10788358 ↗
• MalfunctionSep 25, 2020Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE THE GII SPC REAMTHRU CR TR SZ 6 LT WAS FOUND TO BE CRACKED. NO PATIENT AFFECTATION. NO DELAY. NO BACK UP APPLICABLE FOR THIS CASE. 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 10590453 ↗
• MalfunctionAug 10, 2020Break; Break

  IT WAS REPORTED THAT AFTER SURGERY THE GII SPC REAMTHRU CR TR SZ 6 LT WAS FOUND BROKEN. NO DELAY. NO BACK UP NEEDED. 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 Patient Involvement

  MAUDE report 10388270 ↗
• MalfunctionJun 2, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE HOUSING REAMER COULD NOT BE REMOVED FROM THE FEMORAL TRIAL. THE SCREWS ON A POSTERIOR STABILIZED REAMER HOUSING SEPARATED. ANOTHER NARROW FEMORAL TRIAL SIZE 6 WAS USED TO FINISH THE PROCEDURE WITHOUT DELAYS. PATIENT WAS NOT HARMED IN ANY WAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10109101 ↗

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