GENESIS II 71420191Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010206381), received between May 1, 2017 and Nov 27, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, IT WAS DETECTED THAT A GNS II CEM TIB SIZE 8 RIGHT (71420191) WAS IMPLANTED WITH A JRNY II CR FEM OX NP RT SZ 8 (74021158) AND A JII MD XLPE ART ISRT SZ 7-8 RT 11MM (74021483) ON A PATIENT. GENESIS AND JOURNEY IMPLANTS ARE NOT COMPATIBLE. NO ISSUE WAS NOTICED INTRA-OPERATIVELY WHEN LOCKING THE INSERT INTO THE BASEPLATE. THE SURGEON ATTRIBUTES THIS INCIDENT TO THE FOLLOWING FACTORS: (I) AN INCORRECT PRODUCT WAS ON THE SHELF WHEN IT SHOULD NOT HAVE BEEN, AND (II) THE PRODUCT LABELING BETWEEN GENESIS II AND JOURNEY II BASEPLATES IS FAR TOO SIMILAR. IT IS UNKNOWN IF THIS HAS CAUSED ANY ISSUE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212887 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY AND DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A LEGION PRIMARY SYSTEM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17221325 ↗
• InjuryFeb 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED ASEPTIC LOOSENING ON (B)(6) 2022. A REVISION SURGERY WAS PERFORMED ON (B)(6)2022 TO EXPLANT A GNS II CEM TIB SIZE 8 RIGHT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 13457858 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO SEPSIS PRESENT. ALL IMPLANTS WERE REMOVED. ALSO, A WASHOUT WAS DONE AND A CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8371986 ↗
• InjuryDec 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY, PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO UNCONTROLLED PAIN AND POSSIBLE ACUTE INFECTION. PATIENT HAD BASELINE RIGHT THIGH PAIN RADIATING FROM HIS BACK, BUT REPORTS THAT PAIN HAD GOTTEN A BIT WORSE AFTER SURGERY. PATIENT RECEIVED AN MRI. TOLERATING PO. PAIN WAS CONTROLLED WITH MORPHINE SR. PATIENT WAS FEBRILE (99.6) HAD A SWOLLEN AND PAINFUL KNEE. HE WAS ADMITTED FOR FEBRILE WORKUP, OBSERVATION AND POSSIBLE WASHOUT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8167850 ↗
• InjuryOct 1, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY AFTER TKA IN 2012 AND POST RESURFACING OF THE PATELLA PLUS INCREASE IN THE THICKNESS OF THE POLY INSERT TO 13MM IN 2014. A REVISION SURGERY WAS PERFORMED AND THE TIBIAL BASEPLATE, FEMORAL COMPONENT AND THE POLY INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 7924876 ↗
• InjuryJun 19, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A LEFT KNEE REVISION WAS PERFORMED DUE TO SUBSIDENCE AND LOOSENING OF THE LEFT TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 6651831 ↗
• InjuryJun 19, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A RIGHT KNEE REVISION WAS PERFORMED DUE TO SUBSIDENCE AND LOOSENING OF THE RIGHT TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 6651133 ↗
• InjuryMay 1, 2017Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  REVISION FOR A GENESIS II TIBIAL BASEPLATE WAS PERFORMED FOR SUSPECTED PERI-PROSTHETIC FRACTURE 4 WEEKS POST OP.

  Patient problems: Injury; No Information

  MAUDE report 6533700 ↗

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-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic