GENESIS II 71421523Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010492982), received between Jul 27, 2018 and Oct 19, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K032295); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED IN 2009, THE TENON OF ONE (1) GII PS HI FLEX ISRT SZ 7-8 11 BROKE. THE PATIENT EXPERIENCED RECURRENT JOINT BLOCKAGES, INSTABILITY AND SYNOVITIS, SO AN ARTHROSCOPY WAS THEN PERFORMED AND REVEALED A FRACTURE OF THE INLAY WITH REMOVAL OF THE PEG. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024 IN WHICH WITH REPLACEMENT OF THE INSERT. THE PATIENT HEALTH STATUS IS PHYSICALLY ACTIVE AND DOES NOT PARTICIPATE IN HIGH-RISK SPORTS. POSTOPERATIVE REHABILITATION AFTER THE REVISION SURGERY WENT SMOOTHLY.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Joint locking; Swelling/ Edema; Synovitis

  MAUDE report 20489499 ↗
• InjuryMar 28, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED INSERT DAMAGED, OSTEOLYSIS AND LOOSENING OF IMPLANTS. THIS ADVERSE EVENT WAS SOLVED THROUGH A REVISION SURGERY PERFORMED ON (B)(6)2023, IN WHICH THE GII PS HI FLEX ISRT SZ 7-8 11, LEGION PS OXIN FEM SZ6 RT AND GNS II RESURF PAT 35MM WERE EXPLANTED AND CHANGED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 16632594 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON 2011, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 7-8 11MM. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 15496219 ↗
• InjuryFeb 28, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN AND INSTABILITY DUE TO THE PEG OF THE POLY HAD BROKEN OFF AND THERE WAS LOT OF WEAR. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY TO EXCHANGE THE GII PS HI FLEX ISRT SZ 7-8 11 WITH A CONSTRAINED POLY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS GOOD.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 13619554 ↗
• InjuryJul 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A LOOSE PATELLA. PATELLA AND INSERT WERE EXCHANGED.

  Patient problems: Injury

  MAUDE report 8823649 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ANTERIOR BASE LEFT KNEE PAIN.

  Patient problems: Intraoperative Pain

  MAUDE report 7924486 ↗
• InjuryOct 1, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT FELL AND INJURED HIS RIGHT KNEE. HE DIDN'T SEEK MEDICAL ASSISTANCE FOR 12 MONTHS. WITHIN THAT TIME, THE TIBIAL BASE PLATE HAS PROGRESSIVELY GONE INTO VARUS CAUSING PAIN. DOCTOR BELIEVES THAT THE PATIENT FRACTURED UNDER THE TIBIAL TRAY IN THEIR FALL WHICH CAUSED THE TIBIAL TRAY TO FALL INTO VARUS.

  Patient problems: Injury; Pain

  MAUDE report 7921504 ↗
• InjuryJul 27, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN TRYING TO IMPLANT THE ARTICULAR INSERT IT DIDN'T WANT TO LOCK IN PLACE CORRECTLY. AFTER NUMEROUS ATTEMPTS A NEW INSERT NEEDED TO ORDERED AND DELIVERED FROM S&N. DELAY GREATER THAN 30 MINUTES OCCURED DURING SURGERY.

  Patient problems: Injury

  MAUDE report 7726923 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295. One submission often covers many models, so check the product and lot details in each record.

• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic