GENESIS II 71420490Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010207890), received between May 9, 2017 and Sep 23, 2025 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) GII C/R ART INS SZ 3-4 9MM DID NOT FIT PROPERLY AND CAME OUT OF THE TIBIAL BASEPLATE DURING REDUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT AS THERE WERE NO MORE CR INSERTS AVAILABLE, A PS INSERT HAD TO BE USED. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE. NO ADDITIONAL ANESTHETIC WAS REQUIRED. PATIENT CURRENT HEALTH STATUS IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23125035 ↗
• InjuryNov 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) 2016, THE PATIENT UNDERWENT A POLY EXCHANGE ON (B)(6) 2024 DUE TO UNKNOWN REASONS. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20788388 ↗
• MalfunctionOct 27, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP/INSPECTION FOR TKA SURGERY, IT WAS NOTICED THAT THE INNERMOST STERILE PACKAGING OF A GII C/R ART INS SZ 3-4 9MM WAS NOT SEALED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021372 ↗
• InjuryFeb 17, 2023Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER A RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2007 WITH OSTEOARTHRITIS AS PRIMARY DIAGNOSIS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2015 DUE TO THE FOLLOWING DIAGNOSIS/COMPLICATION(S): WEAR OF POLYETHYLENE COMPONENT AND IMPLANT FRACTURE. DURING THIS PROCEDURE, ALL THE COMPONENTS EXCEPT THE PATELLA WERE EXPLANTED AND REPLACED WITH A SMITH + NEPHEW KNEE REVISION SYSTEM. PER THE REGISTRY REPORT CONTENTS, IT IS NOT SPECIFIED WHICH OF THE EXPLANTED KNEE PROSTHESIS COMPONENTS FRACTURED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY TKR SURGERY WITH A KNEE PROSTHESIS CONSTRUCT THAT INCLUDED A GENESIS II OXINIUM FEMORAL COMPONENTS AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16395893 ↗
• InjuryDec 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) GENESIS II CRUCIATE RETAINING ARTICULAR INSERT SIZE 3-4 9MM BROKE DURING CEMENTING/SETTING. ALL PIECES WERE REMOVED WITH PICK UPS AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948836 ↗
• 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 13-SEP-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; Implant Pain; Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 12595376 ↗
• MalfunctionApr 23, 2021Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY GENESIS II C/R ART INS SIZE 3-4 9MM INLAY COULD NOT BE FIRMLY ANCHORED TO THE TIBIAL COMPONENT INTRAOPERATIVELY. THE EVENT OCCURRED DURING USE AND THE DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713206 ↗
• MalfunctionApr 18, 2021Positioning Failure; Loose or Intermittent Connection; Positioning Failure; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA A GENESIS II C/R ART INS SIZE 3-4 9MM DID NOT ANCHOR FIRMLY TO THE TIBIAL COMPONENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683535 ↗
• MalfunctionDec 28, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE GENESIS II CRUCIATE RETAINING ARTICULAR INSERT SIZE 3-4 9MM WOULD NOT LOCK INTO TIBIA. PROCEDURE CONCLUDED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY OR INJURY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11083544 ↗
• MalfunctionDec 14, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURIG A TKA SURGERY, WHILE INSTALLING THE NO. 3-4 9 MM INSERT, IT WAS FOUND THAT THE INSERT COULD NOT BE TIGHTLY FIXED WITH THE TIBIAL BASEPLATE. THE LOCKING MECHANISM WAS OBSERVED WITH NO OBVIOUS DEFORMATION OF THE INSERT, AND FINALLY ANOTHER SAME SIZE INSERT WAS USED TO FINISH THE SURGERY SMOOTHLY. IT IS UNKNOWN IF THERE WAS A DELAY FOR THIS EVENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002055 ↗
• MalfunctionSep 23, 2020Connection Problem; Incomplete or Inadequate Connection; Connection Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE ITEM WAS NOT LOCKING PROPERLY. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10571845 ↗
• InjuryJan 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STANDARD POLY EXCHANGE WAS PERFORMED ON A PATIENT WITH A LEGION TOTAL KNEE. THE INITIAL SURGERY ON THIS PATIENT WAS PERFORMED IN 2008. UPON REMOVAL OF THE INSERT, IT WAS NOTICED SOME POSTERIOR WEAR IN THE POLY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 9622385 ↗
• InjuryJan 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION WAS PERFORMED DUE TO PERIPROSTHETIC INFECTION OF THE LEFT KNEE. THREE COMPONENTS WERE EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9566755 ↗
• InjuryFeb 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO INSTABILITY. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: Injury

  MAUDE report 8369975 ↗
• MalfunctionDec 28, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE INSERT COULD NOT BE IMPLANTED, BACKUP USED NOT FROM SMITH AND NEPHEW. DELAY 0-30 MIN AND NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203852 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO EXTREMELY UNSTABLE PRIMARY TOTAL KNEE REPLACEMENT.

  Patient problems: Injury

  MAUDE report 7134517 ↗
• InjuryMay 9, 2017Connection Problem; Connection Problem

  IT WAS REPORTED A SURGERY WAS DELAYED BY MORE THAN 30 MINUTES DUE TO AN INSERT THAT WOULD NOT LOCK INTO THE TIBIAL BASEPLATE. ANOTHER INSERT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553909 ↗

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