GENESIS II 71420570Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010208279), received between Oct 1, 2018 and Feb 21, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN IN THE PATELLA. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025. UPON OPENING THE KNEE, IT WAS REPORTEDLY OBVIOUS THAT THE PATELLA BUTTON HAD LOOSENED AS IT WAS LOOSE IN THE JOINT. UPON INSPECTION, IT LOOKED LIKE THE CEMENT DID NOT ADHERE TO THE VERY SCLEROTIC BONE OF THE NATIVE PATELLA. THE PATELLA WAS CUT FLAT, AND A GEN II OVAL PATELLA WAS PLACED ON. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 21434374 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA PRIMARY SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED ONGOING PATELLA PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKA SURGERY ON (B)(6) 2024, IN WHICH THE GNS II BICONVEX PAT 29 MM WAS EXPLANTED. THE REVISION SURGERY WAS PERFORMED IN A PART OF THE STATE DIFFERENT THAN THE PRIMARY SURGERY SITE, BY ANOTHER SURGEON. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN BUT RECOVERING FROM SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 20515962 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A LEFT TKA REVISION DUE TO INSTABILITY AS PRIMARY DIAGNOSIS. APPROXIMATELY SIXTEEN (16) MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED PATELLA MALTRACKING OF THE REVISED KNEE AND REQUIRED A SECOND REVISION. THE DATES IN WHICH THE INDEX SURGERY, FIRST REVISION AND SECOND REVISION TOOK PLACE ARE NOT KNOWN. IT IS ALSO UNKNOWN WHICH DEVICES WERE EXPLANTED AND/OR EXCHANGED DURING THE SECOND REVISION. THIS INCIDENT WAS IDENTIFIED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING TKA REVISION OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 16210906 ↗
• InjuryDec 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT HAD A REVISION SURGERY ON (B)(6)2022, WHERE A GNS II BICONVEX PAT 29MM WAS EXPLANTED DUE TO LOOSENING. THE SURGEON DID NOT FAULT THE PRODUCT. PRIMARY SURGERY DATE AND PATIENT CURRENT HEALTH STATUS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062579 ↗
• InjuryJul 7, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN. ON (B)(6) 2019, A PATELLA RESURFACING WAS PERFORMED USING A GENESIS II BICONVEX PAT 29MM BUT THE PAIN PERSISTED. THE SURGEON NOTED THAT THE PATELLA IMPLANT WAS NOT IN AN OPTIMAL POSITION (SUPERIOR AND MEDIAL), AND THAT WAS CAUSING THE PAIN. THIS ADVERSE EVENT WAS SOLVED BY A PATELLA REVISION ON (B)(6) 2021; THE PATELLA WAS EASILY REMOVED, THE SURGEON DEFINED THE MARGINS OF THE PATELLA AND IMPLANTED A GEN II RESURFACING PATELLA 38MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12130098 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PATELLA PAIN. THERE WAS NO SIGN OF FEMUR OR TIBIA LOOSENING. IT WAS DECIDED TO REMOVE PATELLA AND REPLACE WITH LARGER SIZE AND REPLACED EXISTING POLY WITH NEW ONE OF THE SAME SIZE. NO DELAY REPORTED.

  Patient problems: Pain

  MAUDE report 11247666 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION KNEE SURGERY OF THE GENESIS II BICONVEX PATELLA WAS PERFORMED. THE REASON WHY THE REVISION SURGERY WAS PERFORMED IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11113513 ↗
• InjuryJun 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY OF THE BICONVEX PATELLA WAS PERFORMED FOR GROSS LOOSENING. THE PRIMARY SURGERY WAS PERFORMED IN 2017 BY THE SAME SURGEON.

  Patient problems: No Information

  MAUDE report 10177283 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE ARTHROFIBROSIS AFTER A TKR. THE EVENT WAS RESOLVED VIA MUA, WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9832152 ↗
• InjuryNov 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A BICONVEX PATELLA COMPONENT THAT GOT A GROSS LOOSENING. REVISED TO INLAY RESURFACING PATELLA ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9281456 ↗
• InjuryAug 13, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY OF THE PATELLA WAS PERFORMED DUE TO A LOOSENING.

  Patient problems: Injury

  MAUDE report 8890928 ↗
• InjuryJul 14, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A BICONVEX PATELLA WAS REVISED AT 5 YEARS FOR GROSS LOOSENING. NO KNOWN CAUSE. REVISED TO INLAY 3 PEG PATELLA. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8787558 ↗
• InjuryJun 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAS A TIBIAL FRACTURE AND AN INFECTION WAS ALSO CONFIRMED. THEREFORE A REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8663108 ↗
• InjuryApr 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FLEXION INSTABILITY AND TIGHTNESS LATERALLY. TIBIA, PATELLA, INSERT, FEMORAL WERE EXPLANTED AND REPLACED WITH COMPETITORS DEVICES.

  Patient problems: Injury

  MAUDE report 8547348 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INCREASED PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8146348 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT STATUS POST RIGHT TKA HAD BEEN EXPERIENCING AN MRSA INFECTION FOR WHICH SHE DID CONTINUE ON THE CHRONIC PROPHYLAXIS ANTIBIOTICS. DUE TO SWELLING AND THE PREVIOUSLY ORDERED LABORATORY STUDIES, AN ASPIRATION WAS PERFORMED. AFTER 1% LIDOCAINE WAS USED FOR ANESTHESIA PURPOSES, AN 18 GAUGE NEEDLE WAS USED TO ASPIRATE THE KNEE AND APPROXIMATELY 25-30 CC OF THIN SEROUS FLUID BLOOD TINGED WAS OBTAINED. SHE USED A KNEE IMMOBILIZER FOR AMBULATION ON THE RIGHT AND A REGULAR WALKER, SHE ALSO WAS PRESCRIBED WITH TRAMADOL.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8134008 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2016, HAD BEEN TREATED WITH P.O. ANTIBIOTICS. SHE PRESENTED REDNESS AND SWELLING WITH SLOW HEALING AND POSSIBLE CELLULITIS AND DEEP INFECTION. HER KNEE JOINT WAS ASPIRATED FOR A 1CC OF BLOODY FLUID. SHE WAS ADMITTED TO THE HOSPITAL FOR IV ANTIBIOTICS, VANCOMYCIN WAS PRESCRIBED. SHE MAY HAD REQUIRED SURGICAL DEBRIDEMENT, IRRIGATION AND ANTIBIOTIC BEADS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8133163 ↗
• InjuryOct 1, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF PATELLA COMPONENT. IMPLANTED IN 2014 WITH SUBSEQUENT X-RAY EVIDENCE OF LUCID LINE, SURGICALLY LOOSE, EXPLANTED AND REVISED TO INLAY RESURFACING PATELLA.

  Patient problems: Injury

  MAUDE report 7921501 ↗

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