GENESIS II 71421115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010469298), received between Feb 26, 2019 and Jul 28, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K022010, K962557); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION SUMMARY: "IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO UNKNOWN REASONS. THE FOLLOWING DEVICES WERE EXPLANTED: ONE (1) GII OXIN P/S FEM RIGHT SZ 5, ONE (1) GNS II CMT TIB SIZE 4 {} RIGHT AND ONE (1) LGN PS HIGH FLEX XLPE SZ 3-4 9MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 22628334 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED IN (B)(6) 2022, HAD A KNEE PROSTHESIS OF AN S+N PRODUCT, SINCE THEN THE PATIENT HAVE HAD A RECURRENT PAIN. IT WAS DIAGNOSED THAT IN THE PS VARIANT A RETRO-PATELLAR GRAFT IS NEEDED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 21260901 ↗
• InjuryOct 18, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED RIGHT KNEE PAIN AND EFFUSION. THIS ADVERSE EVENT WAS TREATED BY DOING A WOUND DEBRIDEMENT ON (B)(6) 2021. DURING THE SAID PROCEDURE, THE SURGEON FOUND SIGNS OF METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO METALLOSIS AND IMPLANT LOOSENING. DURING THIS PROCEDURE, THE FEMORAL COMPONENT, INSERT AND TIBIAL COMPONENT WERE EXPLANTED FROM THE PATIENT. CURRENTLY THE PATIENT CONDITION IS STABLE AFTER REVISION SURGERY AND IS IN THE PROCESS OF RECOVERY.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Infiltration into Tissue; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 12647305 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY PERFORMED ON 2016. IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT FELT AN UNUSUAL SENSATION WHEN STANDING UP FROM A SEATED POSITION, THE JOINT FELT LOOSE AND HAD A CLICKING NOISE. PATIENT KNEE AND LOWER LEG STARTED TO SWELL AND PAIN INCREASED. A SCAN WAS PERFORMED AT (B)(6) HOSPITAL, WHERE THEY DIAGNOSED A BURST BAKERS CYST. IN (B)(6), PATIENT CONTACTED HER SURGEON; A JOINT X-RAY WAS PERFORMED, DOCTOR DIAGNOSED A BROKEN AND DISPLACED INSERT. A REVISION SURGERY WAS PERFORMED TO CORRECT THE ISSUE. DURING THE OPERATION IT WAS DISCOVERED THAT THE POST ON THE INSERT HAD SHEARED OFF AND THE METAL PARTS HAD WORN ON EACH OTHER LEAVING SIGNIFICANT METALLIC DEBRIS AROUND THE JOINT AND METALLOSIS. SINCE THEN, THE SECOND KNEE HAS TAKEN MUCH LONGER TO RECOVER AND PATIENT STILL NEEDS THE AID OF CRUTCHES TO WALK SIGNIFICANT DISTANCES AND REQUIRES THE NIGHTLY USE OF DICLOFENAC 3% GEL.

  Patient problems: Injury

  MAUDE report 9482275 ↗
• InjuryApr 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A ASEPTIC LOOSENING OF TIBIA.

  Patient problems: Injury

  MAUDE report 8547110 ↗
• InjuryFeb 26, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO 2.5 YEARS SINCE IMPLANTATION OF THE GENESIS II PS PRIMARY KNEE REPLACEMENT. DUE TO THE INSERT PS PEG HAVING FRACTURED AND THE WHOLE POLYETHYLENE HAVING DISLOCATED THE FEMORAL COMPONENT WAS ARTICULATING ON THE TIBIA AND ERODED THE MEDIAL FEMORAL CONDYLE OF THE OXINIUM TKR COMPONENT. THE PATIENT REQUIRED A REVISION PROCEDURE TO A LEGION REVISION PROSTHESIS, MAINTAINING THE PATELLA. DURING THE REVISION PROCEDURE, IT WAS DISCOVERED THE PS POST ON THE PRIMARY INSERT HAD BROKEN AND THE KNEE SUBLUXED POSTERIORLY, WHICH IS THOUGHT TO HAVE CAUSED THE DISLOCATION OF THE INSERT FROM THE TIBIAL BASEPLATE. THE KNEE WAS X-RAYED AND SHOWN TO BE WELL LOCATED AT FOLLOW-UP OF 12-18 MONTHS FOLLOWING THE PRIMARY PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 8370362 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022010, K962557. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic