GENESIS II 71440828Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010469656), received between Aug 26, 2019 and Nov 4, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY, THE WHITE RINGS INSIDE OF TWO (2) GII PRIM FLEX-EXTEN SPACER BLKS WERE BROKEN ON THE FLEXION AND EXTENSION SIDE, AND DID NOT ACCEPT THE SPACER SHIMS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600419 ↗
• MalfunctionAug 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKR SURGERY, IT WAS NOTICED THAT A PLASTIC ASPECT FROM THE GII PRIM FLEX-EXTEN SPACER BLK HAD BROKEN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612392 ↗
• MalfunctionApr 27, 2022Break; Material Discolored; Scratched Material; Break; Material Discolored; Scratched Material

  IT WAS REPORTED THAT A GENESIS II FEMORAL IMPACTOR HAS A BROKEN POST, A GENESIS II PRIMARY FLEXION EXTENSION SPACER BLOCK HAS A BROKEN O-RING, IS SCRATCHED AND DISCOLORED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14224954 ↗
• MalfunctionApr 18, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE, IT WAS NOTICED THAT A PRIMARY SPACER BLOCK IS WORN OUT AND THE RETAINING RINGS ARE BROKEN AND MISSING. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683531 ↗
• MalfunctionAug 26, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, SURGEON BROKE THE LITTLE WHITE RINGS ON THE BACK TABLE TRYING TO INSERT ADDITIONAL SPACERS. S&N BACKUP DEVICE AVAILABLE. NO DELAY. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929016 ↗

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