GENESIS II 71420844Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010209719), received between Jul 27, 2017 and Feb 24, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TK SURGERY PERFORMED ON AN UNSPECIFIED DATE, A PATIENT EXPERIENCED AN UNSTABLE FEELING IN HIS POSTERIOR STABILIZED KNEE. RADIOGRAPHIC AND DIAGNOSTIC INSPECTION, WITH SEVERE ANTERO-POSTERO TRANSLATION. DURING REVISION SURGERY, PERFORMED ON (B)(6) 2025, THE SURGEON FOUND OUT THAT THE POST OF THE INSERT WAS BROKEN. THE INSERT WAS REPLACED WITH A NEW ONE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant; Joint Laxity

  MAUDE report 21454752 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST REVISION TKA SURGERY WAS PERFORMED ON (B)(6) 2015, THE PATIENT WAS NEVER ENTIRELY SYMPTOM-FREE FOLLOWING THE SURGERIES, REPEATEDLY EXPERIENCING SWELLING IN THE LEFT KNEE JOINT AREA AND PAIN SYMPTOMS. ADDITIONALLY, WITH ELEVATED TEMPERATURES UP TO 37.8°C. THE PATIENT CONSULTED AN ORTHOPEDIC SPECIALIST WHO DRAINED A SIGNIFICANT AMOUNT OF FLUID FROM THE LEFT KNEE JOINT. THE DR INITIATED ANTIBIOTIC THERAPY WITH METRONIDAZOLE AND DOXYCYCLINE. ON (B)(6) 2024, THE PATIENT PRESENTED WITH A SEVERELY SWOLLEN KNEE. BASED ON CLEAR CLINICAL AND LABORATORY FINDINGS, IT WAS DETERMINED THAT KNEE TEP EXPLANTATION WAS NECESSARY DUE TO A LATE INFECTION, AS PART OF A PLANNED TWO-STAGE REVISION. THERE WAS SIGNIFICANT WEAR OF THE GII PS INSERT SZ 7-8 9MM, WITH NOTICEABLE ABRASION IN THE SURROUNDING TISSUE. THE PATIENT IS CURRENTLY DOING AS WELL AS CAN BE EXPECTED UNDER THE CIRCUMSTANCES. A SPACER IS IN PLACE, AND THE RE-IMPLANTATION IS PLANNED FOR APPROXIMATELY SIX WEEKS FROM NOW.

  Patient problems: Fever; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 20325463 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA SURGERY WAS PERFORMED ON (B)(6) 2015 THE PATIENT EXPERIENCED EARLY INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2015, IN WHICH A GII PS INSERT SZ 7-8 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology; Unspecified Infection

  MAUDE report 20324393 ↗
• InjuryOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2005, THE PATIENT EXPERIENCED KNEE PAIN AND DISCOMFORT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A GII PS INSERT SZ 7-8 9MM WAS EXCHANGED, WHOSE POSTERIOR STABILIZATION CAM HAD BROKEN. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17940845 ↗
• InjuryFeb 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2009 WITH OSTEOARTHRITIS AND A PREVIOUS UNSPECIFIED TRAUMA AS PRIMARY DIAGNOSES, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2017 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): IMPLANT FRACTURE OF THE ARTICULAR INSERT. DURING THIS PROCEDURE, THE BROKEN INSERT WAS EXPLANTED AND REPLACED WITH A 11MM XLPE INSERT. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY TKR SURGERY WITH A KNEE PROSTHESIS CONSTRUCT THAT INCLUDED A GENESIS II OXINIUM FEMORAL COMPONENTS AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16396001 ↗
• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT AFTER A HIP SURGERY HAD TAKEN PLACE ON (B)(6) 2018, IT WAS FOUND THAT THE PE PIN OF A GENESIS II PS INSERT SIZE 7-8 9MM HAD BROKE AND A REVISION SURGERY TOOK PLACE TO EXTRACT THE IMPLANT ON (B)(6) 2021. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. LOT IS UNREADABLE.

  Patient problems: Failure of Implant

  MAUDE report 12804590 ↗
• InjuryNov 3, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNSPECIFIED DATE, THE IMPLANTED GENESIS II POSTERIOR STABILIZED INSERT SIZE 7-8 9MM BROKE OFF. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12748306 ↗
• InjuryApr 5, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING A RIGHT TKA SURGERY, USING GII PROSTHESIS, IT COULD NOT BE LOCKED WHEN 7-8/9MM INSERT WAS PLACED INTRAOPERATIVELY. THE 7-8/11MM INSERT WAS USED TO COMPLETE THE SURGERY. IT IS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616762 ↗
• InjuryAug 20, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT FALL WHILE BEING AT HOME, THEREFORE REVISION SURGERY WAS NECESSARY, DURING THE REVISION SURGERY THE GENESIS II PS INSERT SIZE 7-8 9MM WAS FOUND TO BE BROKEN. NO OTHER PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10435074 ↗
• InjuryNov 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PAIN. X-RAYS DETERMINED THAT THE INSERT HAD BROKEN. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE INSERT.

  Patient problems: Injury

  MAUDE report 9284321 ↗
• InjuryOct 24, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE INSERT POST. THE PROCEDURE THAT WAS PERFORMED WAS A KNEE POLY SWAP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9235281 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION WAS PERFORMED ON AN INSERT AND SOFT TISSUE WAS CLEAN OUT. A THICKER INSERT WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210570 ↗
• 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 8167845 ↗
• InjuryOct 2, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT (B)(6) WAS DIAGNOSED WITH RIGHT KNEE INSTABILITY AFTER HIS PRIMARY TOTAL KNEE ARTHROPLASTY ON 2012. A REVISION SURGERY WAS PERFORMED AND THE ARTICULAR INSERT WAS REMOVED AND EXCHANGED FOR A LARGER INSERT. ALSO, IT WAS DETERMINED THAT WOULD BE BENEFIT A PATELLA IMPLANT INSERTION SINCE THE PATIENT'S PATELLA INDICATED WEAR.

  Patient problems: No Code Available

  MAUDE report 7927186 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE REVISION WAS PERFORMED DUE TO A DISENGAGED POLY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6746826 ↗

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