GENESIS II 71440326Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010215000), received between Apr 2, 2019 and Aug 6, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Mechanics Altered; Premature Separation; Mechanics Altered; Premature Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE REAMING SHOULD HAVE STOPPED AT THE DEPTH STOP BUT DID NOT, SO THE SURGEON REAMED DEEPER THAN NECESSARY. THE STOPPER OF THE DEPTH STOP WAS NOT WORKING PROPERLY AND THE DEPTH STOP MOVED FROM THE REAMER SHAFT WITH SIMPLE FORCE EVEN THOUGH THE BUTTON OF THE DEPTH STOP WAS NOT PRESSED. THE SURGERY WAS COMPLETED WITH THE SAME REPORTED DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. AFTER THE SURGERY THE PATIENT EXPERIENCED A PATELLAR FRACTURE ON (B)(6) 2024 AS CONSEQUENCE OF THE MALFUNCTION THAT OCCURRED IN THE INITIAL SURGERY. AS TREATMENT, THE PATIENT USED A CAST FOR 6 WEEKS AND PERFORMED WEIGHT-BEARING GAIT UNDER A PROSTHETIC APPLIANCE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Laceration(s)

  MAUDE report 19918170 ↗
• InjuryAug 6, 2024Mechanics Altered; Premature Separation; Mechanics Altered; Premature Separation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, REAMING SHOULD HAVE STOPPED AT GII PATELLAR DEPTH STOP, BUT IT DID NOT, SO THE SURGEON REAMED DEEPER THAN NECESSARY. UPON CHECKING THE DEVICES, THE STOPPER OF THE DEPTH STOP WAS NOT WORKING PROPERLY AND THE DEPTH STOP MOVED WITH SIMPLE FORCE FROM THE GII PATELLAR REAMER SHAFT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE IMPLANTATION OF A BONE FRAGMENT TO COMPLEMENT THE CEMENT FIXATION. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 19918049 ↗
• InjuryApr 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING SURGERY INLAY PATELLA REAMING AND THE DEPTH STOP SLIPPED, RESULTING IN OVER REAMING OF THE PATELLA. SURGEON WAS ABLE TO BONE GRAFT THE DEFECT AND THEN CEMENT THE IMPLANT. DELAY OF 20 MINUTES REPORTED. SURGEON STATES HE NEEDS TO WAIT TO SEE IF ANY ISSUE OCCURRED AS THE PATIENT RECUPERATES.

  Patient problems: Injury

  MAUDE report 8489940 ↗
• InjuryApr 2, 2019Connection Problem; Connection Problem

  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 8475971 ↗

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