GENESIS II 71420778Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010209382), received between Oct 1, 2018 and Feb 9, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN OPENING THE BOX OF ONE (1) GII DISHED INS SZ 5-6 9MM IT WAS FOUND THAT THE DOUBLE STERILE PACKAGES WERE OPEN AND THE INSERT WAS OUT OF THE PACKAGES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291977 ↗
• 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 14074756 ↗
• InjuryApr 9, 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 14068645 ↗
• MalfunctionMar 9, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT, AT THE END OF A TKA PROCEDURE THE SURGEON WAS STRUGGLING TO IMPLANT A GII DISHED INS SZ 5 6 9MM (71420778). IT LOOKED LIKE IT MAY BE IMPINGING ON THE LATERAL SIDE. THE SURGEON THEN TRIED TO IMPLANT A 2ND POLY INSERT (71420778) AND WAS STILL STRUGGLING. AT THIS STAGE THE THEATRE TEAM GOT A 3RD INSERT IN CASE IT WAS NEEDED AND I NOTICED IT WAS A DISHED INSERT. THE SURGEON HAD ALREADY IMPLANTED A GENESIS II CR FEMUR SIZE 8 AND GENESIS TIBIA SIZE 6. A DISHED INSERT IS INCOMPATIBLE WITH THESE COMPONENTS, SO AT THIS STAGE THE SURGEON WAS AWARE AND HE PROCEEDED TO REMOVE THE DISHED INSERT AND IMPLANT A CR INSERT. AT THE START OF THE CASE THE SURGEON CONFIRMED HE WAS PLANNING FOR A CR SURGERY AND DURING THE TRIALING STAGE A CR INSERT WAS TRIALED. WHEN THE SURGEON AND SCRUB NURSE CHECKED THE IMPLANTS WAS NOT SAY ¿DISHED¿ AT ANY POINT, THEREFORE WAS NOT CHECK THE IMPLANTS AT THIS STAGE. SO, IT WAS ONLY MADE AWARE OF THE IMPLANTS BEING DISHED WHEN A THIRD IMPLANT WAS BROUGHT INTO THEATRE. FINALLY A CR INSERT WAS IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. SURGERY WAS GREATER THAN 30MINS DELAYED. PATIENT WAS NOT HARMED. NO FURTHER INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716031 ↗
• MalfunctionMay 28, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A TKR, THE GENESIS II DISHED ARTICULAR INSERT IN THE SIZE 5 WAS NOT ABLE TO BE LOCKED IN THE TIBIAL BASEPLATE. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901511 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A REGISTER REPORT FROM (B)(6) THAT THERE WERE NINE REVISION SURGERIES PERFORMED TO REPLACE THE INSERT IMPLANT GENESIS II DISHED INS SIZE 5-6 9MM. THERE IS NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, PATIENT AND SURGERY DATA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 11479178 ↗
• InjuryApr 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FLEXION INSTABILITY AND TIGHTNESS LATERALLY. TIBIA, PATELLA, INSERT, FEMORAL WERE EXPLANTED AND REPLACED WITH COMPETITORS DEVICES.

  Patient problems: Injury

  MAUDE report 8547349 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 7974360 ↗
• InjuryOct 1, 2018Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY, ARTHROFIBROSIS AND EXCESSIVE VALGUS ANGLE.

  Patient problems: Fibrosis; Injury

  MAUDE report 7921496 ↗

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