GENESIS II 71420574Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03596010208293), received between May 9, 2017 and Feb 21, 2025 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2023, A REVISION SURGERY FOR PATELLAR COMPONENT WAS PERFORMED TO LATERAL RELEASE ON LIGAMENTS AND CONVERSION TO 7.5MM REVISION RESURFACING PATELLAR. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 21434674 ↗
• InjuryNov 4, 2024Adverse 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 PATELLAR TILT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH THE GNS II RESURF PAT 29MM WAS EXCHANGED AND THE PATELLA LATERAL LIGAMENTS WERE RELEASED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 20605806 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE METALLIC RING INSIDE THE GNS II RESURF PAT 29MM CAME OUT OF IT WHILE CEMENTING. THE PIECE OF THE PATELLA WAS REMOVED FROM THE WOUND AND THE WOUND WAS CLOSED. THE PIECES WAS REMOVED AND ACCOUNTED, WITH THE ARTERY FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. THE SURGERY WAS COMPLETED BUT NO OTHER PATELLA WAS IMPLANTED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812298 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14192096 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCES CONSTANT PAIN, SWELLING AND CAN BARELY WALK. A BONE SCAN WAS TAKEN, BUT NO ABNORMALITY HAS BEEN IDENTIFIED. THIS ADVERSE EVENT HAS BEEN TREATED WITH PHYSICAL THERAPY. HOWEVER, THE PATIENT IS CURRENTLY EXPERIENCING THE SAME SYMPTOMS AND CONDITIONS.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 14074826 ↗
• InjuryApr 12, 2021Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN, OSTEONECROSIS AND PATELLA COMPONENT LOOSENING. DURING THE PROCEDURE IT WAS FOUND THAT THE PEGS OF THE PATELLA COMPONENT WERE BROKEN AND DEFORMED. ONLY THE PATELLA COMPONENT WAS EXPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Necrosis; Pain

  MAUDE report 11648484 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A NAVIO-ASSISTED PFA HAD BEEN PERFORMED ON THE RIGHT SIDE, THE PATIENT EXPERIENCED SYNOVITIS AND PAIN. THE ADVERSE EVENT WAS TREATED WITH ARTHROSCOPIC SYNOVECTOMY; IN SUCH SURGERY, THE PATELLA WAS FOUND TO BE DAMAGED AND PROBABLY CAUSED SYNOVITIS TO THE UNSTABLE PATELLOFEMORAL COMPONENT. THE PATIENT IS ABLE TO MOBILISE POST-OPERATIVELY.

  Patient problems: Inadequate Osseointegration; Pain; Synovitis

  MAUDE report 10431956 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A NAVIO-ASSISTED PFA HAD BEEN PERFORMED ON THE RIGHT SIDE, THE PATIENT EXPERIENCED SYNOVITIS AND PAIN. THE ADVERSE EVENT WAS TREATED WITH ARTHROSCOPIC SYNOVECTOMY; IN SUCH SURGERY, THE PATELLA WAS FOUND TO BE DAMAGED AND PROBABLY CAUSED SYNOVITIS TO THE UNSTABLE PATELLOFEMORAL COMPONENT. THE PATIENT IS ABLE TO MOBILISE POST-OPERATIVELY.

  Patient problems: Inadequate Osseointegration; Injury; Pain; Synovitis

  MAUDE report 10422402 ↗
• InjuryJul 13, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017. AFTER 5 MONTHS FROM IMPLANTATION, IT LOOKED LIKE THE PATELLA STARTED TO BE LOOSE. PATELLA COMPONENT AND INSERT WERE REVISED. THE REVISED DEVICES ITSELF WILL NOT RETURNED BUT, PHOTOS WERE SENT.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Injury

  MAUDE report 10268390 ↗
• InjuryApr 22, 2020Adverse 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 AN INFECTION. ALL THE COMPONENTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9988618 ↗
• InjuryFeb 18, 2020Adverse 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 FEELING OF UNWILLINGNESS AND LOOSENING OF THE PATELLA. SURGEON DOES NOT BLAME THE DEVICES.

  Patient problems: Injury

  MAUDE report 9721673 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, IT IS UNKNOWN THE REASON FOR THIS REVISION.

  Patient problems: Injury

  MAUDE report 8862838 ↗
• InjuryNov 28, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORM DUE TO A PATELLA LOOSENING. PATELLA AND INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 8112826 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT KNEE MANIPULATION WAS PERFORMED DUE TO ARTHROFIBROSIS STATUS POST RECENT POLYETHYLENE EXCHANGE.

  Patient problems: Fibrosis

  MAUDE report 7931736 ↗
• InjuryOct 1, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH SEMITENDINOSUS ALLOGRAFT LEFT KNEE AND APPLICATION OF LONG LEG IMMOBILIZER. NO IMPLANTS REMOVED.

  Patient problems: No Code Available

  MAUDE report 7924001 ↗
• InjuryJul 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRIMARY SURGERY WAS ON (B)(6) 2018. PAIN IS NOT DECREASING AND THE RANGE OF MOVEMENT WAS REDUCED. SHE IS NOT ABLE TO EXTEND OR BEND THE KNEE. PATIENT HAS TAKEN CONSTANT PHYSICAL THERAPY BUT WITH NO IMPROVEMENT. THE DOCTOR SUGGEST ANOTHER SURGERY TO REMOVE EXCESSIVE SCAR TISSUE THAT WAS BUILT UP AROUND THE KNEE JOINT, BUT THE OUTCOME IS THE SAME, NO RANGE OF MOTION AND PAIN.

  Patient problems: Injury

  MAUDE report 7708353 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT TIME OF PRIMARY SURGERY THE PATIENT WENT TO GREAT LENGTHS VIA DIET AND MEDICATION TO GAIN CONTROL OVER DIABETES. SINCE THIS TIME THE PATIENT HAS REGRESSED TO NOW BE A POORLY CONTROLLED DIABETIC. THE PATIENT HAS HAD RECURRENT CHEST INFECTIONS TREATED WITH ANTIBIOTICS. RECENTLY DEVELOPED SYMPTOMS OF INFECTED KNEE. ALL IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7703445 ↗
• InjuryJun 27, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATELLA WAS LOOSE AND WAS REMOVED. THE INSERT WAS ALSO EXCHANGED.

  Patient problems: Failure of Implant

  MAUDE report 7643962 ↗
• InjuryMar 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT FELL AND THEN COMPLAINED OF PAIN IN THEIR KNEE. UPON SEEING THE PATIENT, DR. DETERMINED THAT THE PATIENT HAD DAMAGED THEIR PCL. THE PRIMARY KNEE IMPLANTS IN THE PATIENTS KNEE SEEMED TO BE LOOSE. A REVISION WAS DONE TO CORRECT THE PATIENTS KNEE PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7333309 ↗
• InjuryMar 7, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A REVISION SURGERY DUE TO PATELLA LOOSENING. THE SURGEON DECIDED IT IS NOT A PRODUCT FAILURE AND PRODUCT CANNOT BE RETURNED.

  Patient problems: Injury

  MAUDE report 7320163 ↗
• InjuryNov 22, 2017Detachment Of Device Component; Loose or Intermittent Connection; Detachment Of Device Component; Loose or Intermittent Connection

  IT WAS REPORTED A REVISION SURGERY TO REPLACE THE KNEE'S PATELLA DUE TO DISLODGEMENT OF THE IMPLANT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7053459 ↗
• InjurySep 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION KNEE SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6883501 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED A RIGHT TKR REVISION SURGERY WAS PERFORMED DUE TO RIGHT PATELLA FEMORAL PAIN. THE PATELLA WAS REPLACED DURING THE REVISION SURGERY.

  Patient problems: Injury; Pain

  MAUDE report 6880378 ↗
• InjuryMay 9, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION TOOK PLACE DUE TO INFECTION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6554189 ↗

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