GENESIS II 71440448Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010215574), received between May 7, 2018 and Nov 23, 2021 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A GII TIBIAL ALIGNMENT TUBE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865969 ↗
• MalfunctionSep 17, 2021Break; Break

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487861 ↗
• MalfunctionApr 6, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE GENESIS II TIBIAL ALIGNMENT TUBE WILL NOT HOLD THE SPIKED ROD. THE FAILURE WAS DETECTED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624921 ↗
• MalfunctionMar 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A TKA IT WAS NOTICED THAT THE LOCKING LEVER OF A GENESIS II TIBIAL ALIGNMENT TUBE WAS NOT WORKING. A S&N BACK UP WAS AVAILABLE, THERE WAS NO DELAY TO THE CASE, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478863 ↗
• MalfunctionNov 13, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LEVER ON THE GII TIBIAL ALIGNMENT TUBE WAS FOUND NOT LOCKING DOWN. NO CASE RELATED, THEREFORE NO PATIENT 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 10838324 ↗
• MalfunctionMay 27, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON STATES ALIGNMENT TUBE WILL NO LONGER LOCK ON. S&N BACKUP WAS USED. NO DELAY TO PROCEDURE, NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643597 ↗
• MalfunctionJan 28, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY WHEN USING THE TIBIAL ALIGNMENT ASSEMBLY, IT WAS NOTICED THAT THE ANKLE CLAMP WOULD NOT REMAIN TIGHT WITHIN THE ALIGNMENT TUBE , LIKELY DUE TO OVER USE/AGE. NO HARM TO PATIENT, NO DELAY OCCURRED, THE CASE FINISHED FINE.

  Patient problems: No Information

  MAUDE report 8282773 ↗
• MalfunctionJan 21, 2019Unstable; Connection Problem; Unstable; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE ALIGNMENT TUBE IS NOT LOCKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265359 ↗
• MalfunctionNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIAL CUTTING JIG IS NOT FUNCTION PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072037 ↗
• MalfunctionOct 8, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SURGERY THE TIBIAL ALIGNMENT TUBE WAS NOT LOCKING THE CABLE CLAMP PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7945026 ↗
• MalfunctionAug 21, 2018Failure to Capture

  IT WAS REPORTED THAT THE LEVER ON THE ALIGNMENT TUBE WILL NOT CAPTURE THE ALIGNMENT ROD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7803528 ↗
• InjuryJun 29, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PARTS NEED TO BE FORCED INTO POSITION. THE BLOCK WAS LESS SECURELY POSITIONED. A RECUT WAS PERFORMED BECAUSE THE CUT WASN'T AT THE RIGHT SLOPE AND NOT AT THE RIGHT ANGLE. IT IS UNKNOWN WHICH OF THE DEVICES WAS INVOLVED IN THE MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650729 ↗
• InjuryJun 15, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE TIBIAL ALIGNMENT GUIDE PIECES ARE NOT CONNECTING CORRECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 7604393 ↗
• InjuryMay 7, 2018Difficult To Position; Difficult To Position

  IT WAS REPORTED THAT THE TIBIAL ALIGNMENT GUIDE COULDN'T BE CLOSED BEFORE FIXING WITH PINS, SO THE SURGEON HAD PROCEED WITH A RECUT.

  Patient problems: Injury

  MAUDE report 7489673 ↗

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