GENESIS II 71420580Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010208323), received between Dec 4, 2017 and Oct 25, 2024 — classified as 13 injuries.

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

6 other recalls cover devices cleared under the same FDA submission (K951987); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PATELLA DISCOMFORT. THIS WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GENESIS II RESURFACING PATELLA 26MM WAS EXPLANTED AND EXCHANGED, IN ADDITION, A RELEASE OF SOFT TISSUE WAS PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 20538227 ↗
• InjuryOct 24, 2024Migration; Migration

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT´S PATELLA STARTED SITTING LATERALLY. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH SOFT TISSUE WAS RELEASED AND ONE (1) GNS II RESURF PAT 26MM WAS REPLACED WITH A NEW BIGGER IMPLANT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20528304 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED KNEE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. PATIENT CURRENT HEALTH STATUS IS STABLE.

  Patient problems: Pain

  MAUDE report 17466700 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2022, THE PATIENT EXPERIENCED KNEE PAIN SINCE THEIR ORIGINAL SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE THE GNS II RESURF PAT 26MM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Arthralgia

  MAUDE report 16011185 ↗
• InjuryJul 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2010 WITH A GENESIS II SYSTEM, THE PATIENT EXPERIENCED INSTABILITY IN THE KNEE FOR A COUPLE OF MONTHS. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022. UPON INSPECTION, IT WAS NOTICED THAT THE GNS II RESURF PAT 26MM WAS LOOSE. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15136591 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT WAS NOT HAPPY WITH THE KNEE MOVEMENT. THIS ISSUE WAS SOLVED ON (B)(6) 2022 BY CHANGING THE PATELLA TRACKING. CURRENT HEALTH STATUS IF THE PATIENT IS UNKNOWN .

  Patient problems: Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209844 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN A REVISION SURGERY TKR, THE PATELLA IMPLANT WAS LOOSE. IT WAS EXPLANTED A 26MM RESURFACING PATELLA AND REVISED WITH A 23MM BICONVEX PATELLA. THE SURGEON ATTRIBUTED THE REASON FOR REVISION TO PATIENT HEAVYWEIGHT (VERY HIGH BMI). PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10317859 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT HAD PAIN OF UNKNOWN REASON. THE DOCTOR SAID THAT THE DEVICES FROM SMITH&NEPHEW WERE NOT DEFECTIVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Insufficient Information; Pain

  MAUDE report 10305255 ↗
• InjuryDec 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury

  MAUDE report 9527985 ↗
• 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 NEVILL HALL HOSPITAL, WHERE THEY DIAGNOSED A BURST BAKERS CYST. IN DECEMBER, 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 9482276 ↗
• 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 8370367 ↗
• InjuryMar 12, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY OF THE PATELLAR COMPONENT WAS PERFORMED DUE TO PATELLA TILT AND LATERAL PATELLA PAIN

  Patient problems: Injury

  MAUDE report 7331060 ↗
• InjuryDec 4, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATELLA BECAME "LOOSE" IN PATIENT. DR (B)(6) REVISED THE PATIENTS KNEE TO CORRECT IT.

  Patient problems: No Code Available

  MAUDE report 7081479 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951987. One submission often covers many models, so check the product and lot details in each record.

• Z-1418-2022 · Jun 27, 2022 · Terminated
  (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
• Z-2774-2020 · Jul 16, 2020 · Open, Classified
  Tibial knee prosthesis
• Z-2883-2018 · Aug 1, 2017 · Terminated
  GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
• Z-0573-2016 · Nov 9, 2015 · Terminated
  Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 kn
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic