GENESIS II 71926225Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00885556043998), received between Apr 4, 2017 and Apr 21, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A TKA, A PATIENT FELL ONTO KNEE AND HAD ANTERIOR KNEE PAIN. THE SURGEON ORDERED X-RAY AND IT WAS OBSERVED THAT A GEN II RESURF PATELLA 38MM HAD LOST FIXATION FROM THE PATELLA. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2026 IN WHICH THE PATELLA WAS RESURFACED USING A GNS II BICONVEX PAT 32MM, A RADICAL SYNOVECTOMY WAS PERFORMED TO TREAT POTENTIAL INFECTION, AND A LGN PS HIGH FLEX XLPE SZ 7-8 12MM WAS CHANGED FOR A LGN PS HIGH FLEX XLPE SZ 7-8 13MM. THE OUTCOME AND CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fall; Pain

  MAUDE report 24940134 ↗
• InjuryJan 17, 2023Material Integrity Problem; Loosening of Implant Not Related to Bone-Ingrowth; Material Integrity Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A PRIMARY TOTAL KNEE SURGERY PERFORMED ON (B)(6) 2020, THE PATIENT SUFFERED TIBIAL SUBSIDENCE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT WHERE THE TIBIAL BASEPLATE, TIBIAL INSERT AND PATELLA WERE EXCHANGED. DURING THE PROCEDURE, IT WAS FOUND THAT THE PATELLA WAS LOOSE AND THE INTEGRITY OF ONE OF THE PEGS APPEARED TO BE COMPROMISED, BUT THE PATELLA APPEARED TO HAVE CEMENT ADHERED. THE TIBIA HAD SUBSIDED, BUT APPEARED TO HAVE CEMENT ADHERED. IN ADDITION, IT IS SUSPECTED THAT THE PATIENT WAS NON-COMPLIANT WITH RECOMMENDED ACTIVITIES, AND IT IS SUSPECTED THAT PERFORMED HIGH-IMPACT ACTIVITIES. PATIENT CURRENT HEALTH STATUS 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; Inadequate Osseointegration

  MAUDE report 16184907 ↗
• InjuryJul 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED A LOOSE PATELLA. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN .

  Patient problems: Failure of Implant

  MAUDE report 14947086 ↗
• InjuryMay 5, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT LED TO A REVISION SURGERY, IN WHICH THE GEN II RESURF PATELLA 38MM WAS FOUND TO BE SHEARED OFF. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information; Subluxation

  MAUDE report 14288601 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID.: ORUS-JOURNEY II BCSMULTI-PMCFU; SUBJECT ID: (B)(6); AE NO.: AE04. IT WAS REPORTED THAT AFTER A TKR SURGERY, PERFORMED ON (B)(6) 2012, WHERE THE FOLLOWING DEVICES WERE IMPLANTED: JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 , JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 7-8 LEFT 9MM , JOURNEY TIBIAL BASEPLATE NONPOROUS LEFT SIZE 8 AND GENESIS II RESURFACING PATELLA 38MM. ON (B)(6) 2012 THE PATIENT PRESENTED A LYMPHEDEMA ON THE LEFT LEG (WHERE THE DEVICES WERE IMPLANTED), ADVERSE EVENT WAS TREATED WITH PHYSICAL THERAPY BUT WAS NOT RESOLVED. PATIENT DIED OF MYELODYSPLASTIC SYNDROME ON (B)(6) 2018, THIS DEATH CAUSE IS NOT RELATED TO THE IMPLANTED DEVICES.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12295358 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PATIENT SHOWED SIGNS OF ASEPTIC LOOSENING OF HIS TIBIAL COMPONENT POST TKR. TIBIAL AND PATELLA COMPONENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396621 ↗
• InjuryNov 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIMARY PROCEDURE WAS PERFORMED IN JANUARY THIS YEAR. ACCORDING TO THE SURGEON, THE PATIENT DISLOCATED THE PATELLA AND HAD A QUADRICEPS INJURY, REQUIRING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) REPAIR. THE INSERT WAS REMOVED AND A SMALLER TRIAL WAS INSERTED (21MM) TO REPAIR THE MPFL.

  Patient problems: Damage to Ligament(s); Joint Dislocation

  MAUDE report 10841667 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LEFT KNEE STIFFNESS. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9900959 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RUPTURE OF LEFT QUAD TENDON POSTOPERATIVE. AN UNSPECIFIED SURGERY WAS PERFORMED TO REMEDIATE IT.

  Patient problems: Injury; Rupture

  MAUDE report 9451122 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT EXTENSOR MECHANISM RECONSTRUCTION SURGERY WAS PERFORMED POSTOPERATIVE.

  Patient problems: Injury

  MAUDE report 9445610 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH BETADINE AND ANTIBIOTIC DUE TO A SUTURE REACTION. THE EVENT WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 8967377 ↗
• InjuryAug 26, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

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

  Patient problems: Injury

  MAUDE report 8929155 ↗
• InjuryAug 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT LOWER EXTREMITY EDEMA WITH EXCESSIVE WOUND DRAINAGE, RIGHT FEMORAL DEEP VEIN THROMBOSIS WITH ECCHYMOSIS ABOUT RIGHT THIGH. EVENT WAS RESOLVED WITH MEDICATION.

  Patient problems: Injury; No Code Available

  MAUDE report 8928694 ↗
• InjuryJun 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CLOSED MANIPULATION UNDER ANESTHESIA HAS BEEN DONE DUE TO STIFFNESS IN THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8746836 ↗
• InjuryJun 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT HEARTBURN/CHEST PAIN FOR WEEKS PRIOR TO HOSPITALIZATION, HE BELIEVED THIS WAS DUE TO GERD. HE WAS THEN ADMITTED TO THE HOSPITAL AND REQUIRED STENT AND BYPASS AFTER CARDIAC TESTING.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 8725630 ↗
• InjuryJun 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER 8 WEEKS POST-OP, THE PATIENT STILL HAD LIMITED RANGE OF MOTION AFTER AGGRESSIVE PHYSICAL THERAPY, FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED DUE TO THE STIFFNESS.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8725619 ↗
• InjuryJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED PES ANSERINUS WHICH WAS TREATED USING REPEAT DEPO MEDROL STEROID INJECTIONS.

  Patient problems: Injury

  MAUDE report 8683721 ↗
• InjuryJun 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LIMITED RANGE OF MOTION DURING 6 WEEKS POST OP VISIT, AND IT PROCEEDED WITH MANIPULATION UNDER ANESTHESIA. POST OP VISIT AFTER MUA, THE PATIENT WAS GIVEN DYNASPLINT TO IMPROVE EXTENSION. 6 WEEKS POST MUA PATIENT'S RANGE OF MOTION WAS SIGNIFICANTLY IMPROVED.

  Patient problems: Injury

  MAUDE report 8683711 ↗
• InjuryJun 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER 6 WEEKS POST OP, PATIENT STILL DID NOT HAVE FULL FLEXION AND DECIDED TO PROCEED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 8676615 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ARTHROCENTESIS OF RIGHT KNEE DUE TO CHRONIC PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8349629 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FLUOROSCOPICALLY GUIDED RIGHT TKA ASPIRATION WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8348624 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO CONSISTENT PAIN.

  Patient problems: Pain

  MAUDE report 8348589 ↗
• InjuryJan 2, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT 6 YEARS AFTER PRIMARY TKA, PATIENT NEEDED A REVISION SURGERY DUE TO A FALL AND THE PATELLA WAS FOUND TO BE LOOSE.

  Patient problems: Injury

  MAUDE report 8210530 ↗
• InjuryDec 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POLYETHYLENE INSERT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED DUE TO INFECTION THAT WAS CAUSING PAIN WITH SWELLING AND INABILITY TO WALK. ALSO, IRRIGATION AND DEBRIDEMENT WERE DONE IN THE SAME SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8161251 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A MEDICAL INTERVENTION IN WHICH IT WAS REQUIRED TO ASPIRATE THE LEFT KNEE TO PREVENT INFECTION IN THE PERIPROSTHETIC AREA.

  Patient problems: Injury

  MAUDE report 7924164 ↗

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