GENESIS II 71420566Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 03596010208255), received between Jul 23, 2018 and Jun 15, 2026 — classified as 39 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN. AN X-RAY WAS DONE AND IT WAS NOTICED THAT THE PATIENT PATELLA HAD DISLODGED AND BECOME LOOSE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A GNS II BICONVEX PAT 23MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25498005 ↗
• InjuryNov 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED DISASSOCIATION OF THE GNS II BICONVEX PAT 23MM. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKA SURGERY ON (B)(6) 2025, IN WHICH THE PATELLA COMPONENT WAS EXCHANGED TO A NEW ONE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23460420 ↗
• InjuryJul 14, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED LOOSENING OF THE PATELLAR COMPONENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE GNS II BICONVEX PAT 23MM AND THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM WERE EXPLANTED AND EXCHANGED. THE JOURNEY TIBIA BASE NP LT SZ 3 AND THE JRNY II BCS FEM COCR LT SZ 3 REMAINED ON THE PATIENT. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 22493121 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED TIBIAL SAGGING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(60 2025, IN WHICH ONE (1) GNS II BICONVEX PAT 23MM AND ONE (1) JRNY II CR ISRT XLPE LT SZ 1-2 10MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 21322714 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED HEMARTHROSIS AND MUSCLE WEAKNESS WAS ALSO OBSERVED. THIS ADVERSE EVENT WAS TREATED BY REMOVING HEMARTHROSIS SEVERAL OCCASIONS BY DRAINING IT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 18751694 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED HEMARTHROSIS AND MUSCLE WEAKNESS WAS ALSO OBSERVED. THIS ADVERSE EVENT WAS TREATED BY REMOVING HEMARTHROSIS SEVERAL OCCASIONS BY DRAINING IT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 18751550 ↗
• MalfunctionDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA WHEN SETTING THE PATELLA COMPONENT, THE RING OF ONE (1) 23MM GENESIS II BICONVEX PATELLA WAS DETACHED WITHOUT TOUCHING. THE RING WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307472 ↗
• InjuryNov 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, FOUR (4) MONTHS AFTER A TKA WAS PERFORMED IN 2019, THE PATIENT EXPERIENCED A FALL. THIS EVENT WAS TREATED CONSERVATIVELY UNTIL THE PATIENT STARTED EXPERIENCING ANTERIOR KNEE PAIN. A BONE SCAN REVEALED THAT THE PATELLAR COMPONENT WAS LOOSE. THIS COMPLICATION WAS TREATED BY REPLACING THE 32MM GENESIS II BICONVEX PATELLAR COMPONENT WITH A 32MM GENESIS II OVAL PATELLAR COMPONENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fall; Implant Pain; Inadequate Osseointegration

  MAUDE report 18222718 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN AND AN UNUSUAL FEELING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. FURTHERMORE, ONLY THE PATELLA (GNS II BICONVEX PAT 23MM) WAS EXCHANGED AND THE OTHER IMPLANTS REMAINED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Pain

  MAUDE report 17066933 ↗
• InjuryNov 28, 2022Unintended Collision; Unintended Collision

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT COMPLAINT ABOUT PAIN AND LOSS OF RANGE OF MOTION ONE WEEK LATER. IT WAS FOUND THAT THE GNS II BICONVEX PAT 23MM WAS IMPINGED TO THE FEMORAL COMPONENT DURING KNEE BENDING AND STRETCHING. THE ISSUE WAS SOLVED PERFORMING A REVISION SURGERY ON (B)(6) 2022, TO EXCHANGE THE PATELLA COMPONENT FOR A RESURFACING PATELLA. 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: Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 15873648 ↗
• InjuryJan 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13212788 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED INFECTION, SWELLING AND FEVER FROM PRIMARY SURGERY. THIS ADVERSE EVENT WAS SOLVED BY DOING A REVISION SURGERY TO EXTRACT JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM (CASE- (B)(4)), JRNY II BCS FEMORAL OXIN LT SZ 3 (CASE- (B)(4)), JOURNEY TIBIA BASE NP LT SZ 3 (CASE-(B)(4)) AND GNS II BICONVEX PAT 23MM (CASE- (B)(4)) ON (B)(6) 2021 AND IMPLANT COMPETITOR IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 13002168 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF UNDERWENT MEDICALLY-INDICATED REVISION SURGERY OF THE LEFT KNEE ON (B)(6) 2019 DUE TO CHRONIC PAIN, WHICH THE PATIENT PRESENTED SINCE (B)(6) 2017. DURING THIS PROCEDURE, THE PATELLAR COMPONENT AND THE INSERT WERE EXCHANGED. THE PRIMARY TKR WAS PERFORMED ON (B)(6) 2014. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Extraskeletal ossification; Implant Pain; Insufficient Information; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue

  MAUDE report 12595380 ↗
• InjuryApr 27, 2021Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, A GNS II BICONVEX PAT 23MM LOOSENED AND WORN. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11730225 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT PRESENTED TO THE HOSPITAL WITH A PSYCHIATRIC ILLNESS. DURING THE EVALUATION, THE LEFT KNEE AND LEFT LEG WERE FOUND TO BE SWOLLEN AND PAINFUL PROXIMALLY. THE LEFT KNEE WAS ASPIRATED AND FOUND TO HAVE VISIBLE PUS, SO THE PATIENT WAS BOOKED FOR REVISION OF THE FIRST STAGE OF THE LEFT KNEE ARTHROPLASTY AND REMOVAL OF ALL HARDWARE. A REVISION SURGERY WAS PERFORMED TO REMOVE ALL PROSTHESES AND INSERT AN ANTIBIOTIC SPACER. AFTER REMOVAL OF THE PROSTHESIS, PUS WAS VISUALIZED IN THE TIBIAL AND FEMORAL CANALS, LAVAGE WAS PERFORMED, AND A SPACER WAS INSERTED.

  Patient problems: Bacterial Infection; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 11167479 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF GEN II WAS PERFORMED DUE TO AN UNSPECIFIED REASON. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11018640 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED DUE TO DISLOCATION OF THE GNS II BICONVEX PAT 23MM. THE DOCTOR SAYS THAT THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Failure of Implant

  MAUDE report 10883749 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY OF LEFT KNEE PATELLA WAS PERFORMED TO EXCHANGE THE GENESIS II BICONVEX PATELLA 23MM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 10301226 ↗
• InjuryJun 15, 2020Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT AFTER PRIMARY KNEE SURGERY, THE PATIENT EXPERIENCED PAIN AND DISLOCATION. REVISION SURGERY WAS PERFORMED. THE SURGEON INDICATED THAT THE DEVICES WERE NOT DEFECTIVE BUT THERE WAS A PROBLEM WHEN THE BONES WERE SHAVED. IT WAS TOO SHALLOW TO IMPLANT IT. A BACKUP DEVICE WAS USED AS REPLACEMENT. 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; Joint Dislocation

  MAUDE report 10155637 ↗
• InjuryMay 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE DOCTOR SAYS THE DEVICE WAS NOT DEFECT BUT THE ANGLE WAS NOT APPROPRIATE.

  Patient problems: Injury

  MAUDE report 10022686 ↗
• InjuryFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE FITTING ANGLE OF THE PATELLA INSERT.

  Patient problems: Injury

  MAUDE report 9668883 ↗
• InjuryJan 7, 2020Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND STIFFNESS. SURGEON DETERMINED WRONG SIZED PATELLA HAD BEEN CHOSEN AND IMPLANTED.

  Patient problems: Injury

  MAUDE report 9557767 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE SURGEON STATED THAT IT COULD BE RELATED TO EITHER PAIN OR AN ALLERGIC REACTION. ADDITIONALLY, REPORTS OF THE IMPLANTS ARE NOT NECESSARY AND THEY ARE NOT AVAILABLE FOR EVALUATION. DEVICES WILL BE EXCHANGED FOR CEMENT MOLDS.

  Patient problems: Pain

  MAUDE report 9510748 ↗
• InjuryNov 13, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN, DISASSOCIATION OF THE PATELLA. THE DEVICE WAS REPLACED WITH A GENESIS II RESURFACING PATELLA.

  Patient problems: Pain

  MAUDE report 9315157 ↗
• MalfunctionOct 4, 2019Break; Break

  IT WAS REPORTED THAT AFTER THE IMPLANTATION, A FOREIGN PARTICLE WAS FOUND, AND IT WAS PICKED UP FROM THE PATIENT BODY. IT WAS UNKNOWN IF THE PARTICLE WAS CAUSED BY THE INSTRUMENTS OR IMPLANTS.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9158544 ↗

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