GENESIS 725004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010256805), received between Jan 3, 2019 and Jan 7, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K230653, K912735); 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.

• InjuryJan 7, 2026Fracture

  IT WAS REPORTED THAT AFTER A UKR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE BLADE OF THE GENESIS UNI FEMORAL LARGE WAS BROKEN. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING REVISION SURGERY ON AN UNKNOWN DATE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23989656 ↗
• InjuryDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA WAS PERFORMED ON (B)(6) 2011, THE PATIENT PRESENTED PAIN AND DISCOMFORT DUE TO THE BREAKAGE OF THE GENESIS UNI FEMORAL LARGE. SURGERY TO REMOVE THE BROKEN PIECE WAS PERFORMED ON (B)(6) 2024, REVISION SURGERY NOT SCHEDULED YET.

  Patient problems: Discomfort; Failure of Implant; Implant Pain

  MAUDE report 20984762 ↗
• InjuryMar 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT 17 YEARS AFTER PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO NON-TRAUMATIC BREAKAGE OF THE UNICOMPARTMENTAL FEMORAL COMPONENT PROSTHESIS. TIBIAL BASEPLATE AND INSERT WERE ALSO EXPLANTED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9788416 ↗
• InjuryApr 11, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE BREAKAGE OF THE FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 8504798 ↗
• InjuryJan 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO UNSPECIFIED REASONS. IT WAS REPORTED THAT WHEN ATTACHING THE CHISEL BLADE TO REMOVE A SINGLE-CONDYLAR PROSTHESIS G-II FROM 1ST IMPLANTATION ON (B)(6) OF 2015, THE FEMORAL COMPONENT IMMEDIATELY BECOMES TORN AND BREAKS OFF DIRECTLY AT THE PROXIMAL SHIELD. SURGEON STATES THAT THERE WERE A DISTINCTIVE PE WEAR DUE TO THE VARICOSE JOINT AXIS OF AN IMPLANTED MEDIAL G-II SINGLE-CONDYLAR PROSTHESIS. THE LATERAL FEMORAL CONDYLE ALSO SHOWED CONSIDERABLE CYSTIC DEFECTS DUE TO METAL AND PE ABRASION - SO THAT AFTER EXPLANTATION OF THE MEDIAL SLIDE A LEGION REVISION PROSTHESIS WITH BAR EXTENSION TIBIALLY AND FEMORALLY, POSTERIOR LAT. WEDGE 5 MM FEMORAL AND MEDIAL TIBIAL WEDGE 5 MM AND CC INLAY 11 MM WERE IMPLANTED. ALSO, WAS REPORTED THAT THE FEMORAL AND TIBIAL COMPONENTS THEMSELVES WERE WELL CEMENTED AND NOT LOOSENED.

  Patient problems: Injury

  MAUDE report 8212237 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230653, K912735. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0305-05 · Jun 21, 2004 · Terminated
  Tibial Base Plates
• Z-0304-05 · Jun 21, 2004 · Terminated
  Genesis Uni Articular Inserts