GENESIS II 71421035Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010485076), received between Nov 17, 2017 and Oct 29, 2025 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT HAS SOME FORM OF AVN CAUSING PATELLA TO BECOME LOOSE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A GII OVAL RESURFACING PAT 35MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening; Necrosis

  MAUDE report 23411424 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA, A GII OVAL RESURFACING PAT 35MM WAS REVISED ON (B)(6) 2024 DUE TO UNKNOWN REASONS. PATIENT'S HEALTH STATUS IN UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21055323 ↗
• InjuryFeb 26, 2024Adverse 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) 2017, THE PATIENT EXPERIENCED PAIN AND THE SURGEON WAS NOT SURE OF CAUSE BUT NOTED SOME ABSORPTION OF BONE BEHIND PATELLA. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS REMOVED AND IMPLANTED A NEW PATELLA. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 18777317 ↗
• MalfunctionNov 4, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII OVAL RESURF PAT TRIAL 35MM DEVICE WAS FOUND TO BE GOUDED OUT AND PLASTICS BITS WERE FALLING OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724894 ↗
• InjuryDec 3, 2021Adverse 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) 2021, THE PATIENT EXPERIENCED PAIN APPROXIMATELY 6 MONTHS AFTER TOTAL KNEE REPLACEMENT. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12924077 ↗
• InjuryNov 3, 2021Adverse 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) 2020, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE IMPLANT. THE NATIVE PATELLA HAD A LARGE SCLEROTIC AREA ON THE LATERAL SIDE, WHERE THE CEMENT BONE INTERFACE FAILED, LEADING TO A PATELLA/CEMENT INTERFACE FAILURE MEDIALLY. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2021, IN WHICH THE GII OVAL RESURFACING PAT 35MM WAS EXPLANTED, OLD CEMENT WAS REMOVED, AND THE PATELLA WAS PREPARED WITH MULTIPLE SMALL DRILL HOLES FOR BETTER CEMENT PENETRATION, AND THE SAME SIZED IMPLANT WAS USED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12745472 ↗
• InjuryJul 12, 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, THE PATIENT EXPERIENCED LOOSENING OF THE GENESIS II OVAL RESURFACING PAT 35MM DUE TO WEAR CAUSED BY ABNORMAL STRESS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021 WHERE THE PATELLA WAS CHANGED FOR A 41 MM ONE. THE INSERT WAS ALSO REPLACED DURING THIS SURGERY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12151056 ↗
• InjuryJan 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKR PROCEDURE WAS PERFORMED (B)(6) 2009, THE PATIENT HAD AN ACCIDENT AND DOCTOR BELIEVES HE LANDED ON THE FLEXED KNEE. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT; THE PATELLA IMPLANT DETACHED FROM THE CEMENT WHILE DOING THE SOFT TISSUE CLEAN UP AROUND THE PATELLA, SO IT WAS REPLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11155128 ↗
• 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 PERFORMED BECAUSE OF PAIN AFTER TKA. X RAY SHOWED RADIOLUCENCY AROUND PATELLA. ONLY PATELLAR IMPLANT WAS REVISED.

  Patient problems: Implant Pain

  MAUDE report 10883832 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS ADDRESSED BY PERFORMING A REVISION SURGERY: ALL COMPONENTS WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10766934 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 21 MONTHS AGO THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT FOR HER LEFT KNEE AND SHE IS STILL IN INCREDIBLE PAIN, IT OFTEN FEELS VERY WARM AND VERY TIGHT. THERE IS A LARGE INDENTATION ON THE BOTTOM LEFT OF HER KNEE, AND A "KNIFE STABBING" AND "OUT OF PLACE" SENSATION. THE DOCTOR SAID IT WAS THE IMPLANT OPENING UP WHEN BENT. THE PAIN IS OFTEN BELOW THE KNEECAP. THE PATIENT IS USING A PATELLA BRACE, KINESIO TAPE, PHYSICAL THERAPY AND PUTTING ICE ON THE KNEE.

  Patient problems: Pain

  MAUDE report 10199452 ↗
• InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE ARTHROFIBROSIS. ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 10014321 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED LEFT KNEE HEMARTHROSIS AND CELLULITIS. THE EVENT WAS RESOLVED VIA REVISION SURGERY. THE EVENT IS CONSIDERED ONGOING.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9997281 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT HAD BEEN EXPERIENCING PROBLEMS ASSOCIATED WITH STIFFNESS ON HIS SURGERY KNEE. THE SUBJECT ATTEMPTED PHYSICAL THERAPY BUT ENDED UP DEVELOPING ARTHROFIBROSIS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND ITS OUTCOME IS CONSIDERED UNKNOWN.

  Patient problems: Injury

  MAUDE report 9983916 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED STIFFNESS OF THE RIGHT KNEE FOLLOWING SURGERY. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA. THE OUTCOME OF THE EVENT IS CONSIDERED UNKNOWN.

  Patient problems: Injury

  MAUDE report 9983555 ↗
• InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED FROM LEFT KNEE ARTHROFIBROSIS FOLLOWING A SURGERY. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9911102 ↗
• InjuryAug 30, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT COMPLAINTS ABOUT PAIN AND INSTABILITY. X-RAY SHOWS LOOSENING PATELLA. REVISION SURGERY WILL BE PLANNED IN THE NEAR FUTURE.

  Patient problems: Pain

  MAUDE report 8949421 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKA ON (B)(6) 2016 SURGERY WENT FINE. AFTER 2 YEARS COMPLAINING ABOUT KNEE PAIN. EXAMINATION SHOWED SOME LAXITY NO STRANGE THINGS WHERE FOUND ON THE X RAY. 31ST OF JULY SHE IS STILL IN PAIN. X RAY KNOW SHOWS A LOOSE PATELLA. REVISION SURGERY WILL BE PLANNED IN THE NEAR FURTHER.

  Patient problems: Injury

  MAUDE report 8929069 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ARTHROFIBROSIS RIGHT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED FOR WHICH SUBJECT WAS HOSPITALISED.

  Patient problems: Injury

  MAUDE report 8536327 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PERSISTENT ANTEROLATERAL KNEE PAIN AFTER TKA RIGHT. LATERAL FACETECTOMY AND LATERAL RELEASE TKA RIGHT WAS PERFORMED WITH NO DEVICE CHANGE.

  Patient problems: Pain

  MAUDE report 8536068 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA AND INJECTION OF PERIARTICULAR PAIN COCKTAIL WAS PERFORMED TO A PATIENT DUE TO RIGHT KNEE STIFFNESS, STATUS POST TOTAL KNEE ARTHROPLASTY REVISION.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8156106 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DIAGNOSED WITH RIGHT KNEE STIFFNESS STATUS POST REVISION, AND RIGHT KNEE REPLACEMENT. A MANIPULATION UNDER ANESTHESIA AND AN INJECTION OF PAIN COCKTAIL CONTAINING TORADOL, MORPHINE, EPINEPHRINE AND BUPIVACAINE, IN PERIARTICULAR TISSUES AND INTRA-ARTICULARLY WERE PERFORMED.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8155224 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS MORE THAN THREE MONTHS STATUS POST HER SURGERY, FAILED TO REGAIN FULL RANGE OF MOTION ON HER RIGHT KNEE. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED AND AN INJECTION FOR PAIN CONTROL POSTOPERATIVELY WAS APPLIED ON HER RIGHT KNEE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8155200 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8155174 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS TO RELIEVE JOINT IMMOBILIZATION.

  Patient problems: Injury

  MAUDE report 7697384 ↗

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