GENESIS II 71421029Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 03596010485052), received between Aug 10, 2017 and Jan 9, 2026 — classified as 25 injuries, 2 malfunctions.

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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Malposition of Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII OVAL RESURFACING PAT 29MM WAS CATCHING ON THE MEDIAL RIDGE OF THE BOX OF ONE (1) JRNY II BCS FEMORAL OXIN RT SZ 4. IT WAS NOTICED THAT WHEN CLOSING THE INCISION, THE PATELLA WAS NOT TRACKING CORRECTLY. A POTENTIAL CONCERN WAS NOTED NEAR THE MEDIAL RIDGE OF THE FEMUR COMPONENT BOX. AN ADDITIONAL FEMORAL COMPONENT WAS OPENED FOR EVALUATION AND APPEARED THE SAME. FEMUR TRIALS WERE ALSO SHOWN FOR REASSURANCE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24029075 ↗
• InjuryAug 17, 2023Adverse 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) 2020, THE PATIENT EXPERIENCED PAIN. THE PATIENT´S GII OVAL RESURFACING PAT 29MM FOUND TO NOT BE INTACT PER THE SURGEON, IT DIDN¿T LOOK LIKE IT WAS PROPERLY CEMENTED. WHEN IT WAS TAKEN OFF IT DIDN¿T HAVE ANY CEMENT ON THE BOTTOM OF THE BUTTON. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE GII OVAL RESURFACING PAT 29MM AND JRNY II BCS XLPE ART ISRT SZ 3-4 LT 13MM WERE EXPLANTED. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 13MM WAS EXCHANGED TO A CONSTRAINED FOR BETTER STABILITY; ALSO, IT HAD NO EXCESSIVE WEAR. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 17568666 ↗
• InjuryJun 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT KNEE ON (B)(6) 2020 DUE TO INSTABILITY OF THE TKA. X-RAYS REVEALED TILTING OF THE PATELLA. IT IS UNKNOWN WHICH COMPONENTS WERE EXPLANTED DURING THE REVISION. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THE PRIMARY RIGHT HIP TKR SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: Insufficient Information; Joint Laxity; Subluxation

  MAUDE report 17159982 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14548294 ↗
• InjuryFeb 24, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER A LEFT PFJ SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED EXTREME DAILY PAIN. SINCE THEN, THE PATIENT HAVE HAD 7 UNSPECIFIED SURGERIES TO ADDRESS THE PAIN. ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION SURGERY AND THE HARDWARE THAT WAS TAKEN OUT OF THE KNEE WAS VERY DAMAGED. THE PATIENT IS IN RECOVERY.

  Patient problems: Failure of Implant

  MAUDE report 13591514 ↗
• MalfunctionJan 13, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING A TOTAL KNEE REPLACEMENT SURGERY, UPON OPENING THE GII OVAL RESURFACING PAT 29MM BOX, THE STERILE BAG WAS NOTICED TO BE BROKEN. AN IDENTICAL IMPLANT WAS OPENED AND STERILE BAG WAS GOOD. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252309 ↗
• InjurySep 22, 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) 2019 THE PATIENT SUFFERED FROM PAIN AND INSTABILITY. A REVISION SURGERY WAS NECESSARY TO ADDRESS THIS ADVERSE EVENT. THE PATIENT RECEIVED A TKA SYSTEM WITH UNKNOWN DEVICES. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12516941 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA, PATIENT PRESENTED PAIN. A CT SHOWED HOT SPOTS AND LOOSENING ON TIBIAL COMPONENT AND PATELLA. A TOTAL KNEE REVISION SURGERY WAS PERFORMED TO IMPLANT COMPETITOR'S PRODUCTS. PATIENT OUTCOME UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 11086813 ↗
• InjuryNov 26, 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 AN UNSPECIFIED ADVERSE EVENT. THE PATIENT HAS NEUROLOGICAL ISSUES. A REVISION SURGERY WAS PERFORMED TO EXPLANT GII OVAL RESURFACING PAT 29MM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Nervous System Injury

  MAUDE report 10912658 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A REVISION LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2020. PATIENT HAS COMPLAINED OF ANTERIOR KNEE PAIN INCREASING IN SEVERITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 AND THE PATELLA BONE WAS RESECTED AND NEW RESURFACING PATELLA IMPLANTED. SURGEON BELIEVED THIS WAS 'OVERSTUFFED' FROM X-RAY IMAGES AND PATIENT SYMPTOMS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury; Pain

  MAUDE report 10850391 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS ON THE LEFT KNEE, IT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. THE OUTCOME IS RESOLVED. REHABILITATION WAS PRESCRIBED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Fibrosis

  MAUDE report 10365767 ↗
• InjuryAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE TKA, THE PATIENT PRESENTED A LEFT KNEE STIFFNESS. THE PATIENT WAS TREATED UNDER ANESTHESIA. NOT MORE INFORMATION AVAILABLE AT THE MOMENT, PLEASE SEE THE REQUEST THAT IT WAS ATTACHED.

  Patient problems: Inflammation; Injury; Loss of Range of Motion

  MAUDE report 10360518 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA HAD TO BE PERFORMED ON THE LEFT KNEE. IT IS UNKNOWN THE REASON OF THE ADVERSE EVENT. THE PATIENT OUTCOME WAS SUCCESSFULLY RESOLVED. NO INJURY NOR DELAY HAS BEEN REPORTED.

  Patient problems: Injury

  MAUDE report 10166240 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS OF THE RIGHT KNEE. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842224 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A CONTRACTURE ON THE LEFT KNEE. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842221 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS ON THE RIGHT KNEE JOINT. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842200 ↗
• InjuryJan 6, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AFTER CLOSING THE INCISION IT WAS NOTICED THAT DURING FLEXION THE PATELLA MADE A CLINKING SOUND. IT COULD HAPPEN BECAUSE THE 29 MM PATELLA USED WAS TOO SMALL. THE PATELLA WAS REMOVED AND PLACED A BIGGER ONE FROM A COMPETITOR.

  Patient problems: Injury

  MAUDE report 9553556 ↗
• InjuryJun 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED, 2-4 WEEKS POST OPERATIVE, PATIENT WAS IN REHAB AND WHEN REACHING FOR WALKER TO GET UP OFF TOILET HEARD A CRACKING SOUND. HER DISTAL FEMUR BROKE ABOVE THE FEMORAL COMPONENT, PATIENT WAS HOSPITALIZED, THE IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER BLOCKS WERE IMPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8661508 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SUBJECT WAS HOSPITALISED AND WAS ADMINISTERED WITH ANTIBIOTIC THERAPY AND THE EVENT WAS RESOLVED AFTER 7 DAYS. PUNCTURE WAS TAKEN AND CULTURES WERE NEGATIVE.

  Patient problems: Unspecified Infection

  MAUDE report 8610469 ↗
• InjuryApr 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  POST-OPERATIVE LIMITED RANGE OF MOTION (70 DEGREE) RIGHT KNEE AFTER TKA SURGERY. SUBJECT WAS HOSPITALISED. EVENT REPRESENTS A SERIOUS ADVERSE DEVICE EFFECT.

  Patient problems: Injury

  MAUDE report 8512705 ↗
• InjuryApr 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS AFTER TOTAL KNEE ARTHROPLASTY ON HIS LEFT KNEE. S&N DEVICES CANNOT BE EXCLUDED AS TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED SERIOUS INJURY. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Fibrosis

  MAUDE report 8468279 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON THE PATIENT DUE TO INCREASED PAIN AND REDUCED RANGE OF MOTION. NO INSTABILITY IDENTIFIED, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 8197913 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT AS SHE DEVELOPED ARTHROFIBROSIS.

  Patient problems: No Code Available

  MAUDE report 7928001 ↗
• InjurySep 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED FOR A PATIENT DUE TO A FRACTURE OF THE MEDIAL ASPECT OF LEFT PROXIMAL TIBIAL METAPHYSIS.

  Patient problems: Injury

  MAUDE report 7869398 ↗
• InjurySep 5, 2018Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE LEFT KNEE PRESENTED STIFFNESS; DECREASED ROM. EVENT WAS TREATED WITH SURGICAL PROCEDURE - MANIPULATION UNDER ANESTHESIA. AEMB DISAGREED WITH INVESTIGATOR'S CLASSIFICATION THAT THIS EVENT IS UNRELATED AND HAS CLASSIFIED THIS EVENT ON (B)(6) 2018 AS SERIOUS ADVERSE DEVICE EFFECT (SADE), UNABLE TO EXCLUDE RELATIONSHIP OF S&N DEVICE AS CAUSE OR CONTRIBUTOR TO THIS SERIOUS INJURY, WITH SPECIAL EMPHASIS GIVEN TO SURGICAL TECHNIQUE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 7846792 ↗

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