GENESIS II 71420832Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010209658), received between May 6, 2019 and Mar 8, 2026 — classified as 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2026Positioning Failure; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING A TKA REVISION SURGERY, A GII PS INSERT SZ 5 6 11MM DID NOT FIT PROPERLY BECAUSE THE PATIENT REQUIRED AN ANTHEM INSERT, BUT GENESIS II INSERTS WERE SENT INSTEAD. THE GENESIS II INSERT WAS LEFT AS A PROVISIONAL MEASURE IN THE PATIENT, AWAITING THE USE OF AN APPROPRIATE ONE. ON (B)(6) 2026, A REVISION SURGERY WAS PERFORMED TO REMOVE THE PROVISIONAL INSERT AND REPLACE IT WITH THE APPROPRIATE ONE. CURRENT HEALTH STATUS OF PATIENT IS STABLE.

  Patient problems: Discomfort

  MAUDE report 24542195 ↗
• InjuryMay 9, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED 15 YEARS AGO, THE POST OF ONE (1) GII PS INSERT SZ 5-6 11MM BROKE WHICH MADE HIS KNEE UNSTABLE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE DEVICE WAS EXCHANGED FOR A LGN PS HIGH FLEX XLPE SZ 5-6 13MM. THEY REPORTEDLY WENT UP 2 MM IN INSERT THICKNESS AS THE KNEE SEEMED TO LOOSEN UP. THE CURRENT HEALTH STATUS OF THE PATIENT IS "NORMAL".

  Patient problems: Joint Laxity

  MAUDE report 21991046 ↗
• InjuryDec 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2010, THE POST THAT WAS IMPLANTED BROKE ON THE TIBIAL INSERT. THE PATIENT ONLY EXPERIENCED AN UNSTABLE KNEE. THE WAS NO TRAUMATIC EVENT REPORTED. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A GII PS INSERT SZ 5-6 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS RECOVERED SINCE THE POLY EXCHANGE PROCEDURE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 18302479 ↗
• InjuryAug 9, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 BECAUSE OF A GII PS INSERT SZ 5-6 11MM FAILURE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17487144 ↗
• InjuryMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED A POST BREAKAGE OF A GII PS INSERT SZ 5-6 11MM. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16947720 ↗
• InjuryMay 31, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING SURGERY, WHEN USING THE GII PS INSERT SZ 5-6 11MMT, IT WAS SMALLER AND DID NOT FIT WITH THE TIBIA. THE DOCTOR DECIDES TO PUT A LARGER MEASURE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545550 ↗
• InjuryJan 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT FELT A SUDDEN CRACKING SOUND WHEN BENDING THE KNEE WHILE PUTTING ON A STOCKING ON (B)(6) 2021. AFTER THAT, THE PATIENT HAD HAD AN EXTREMELY UNSAFE FEELING WHEN WALKING. AS THE POST OF A GII PS INSERT SZ 5-6 11MM FRACTURED, IT WAS EXCHANGED IN A REVISION SURGERY ON (B)(6) 2022. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant

  MAUDE report 13389475 ↗
• InjuryDec 16, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKJR SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT REPORTED SUFFERING FROM MAJOR KNEE EFFUSION, LYSIS, POOR ROM AND PAIN. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE TIBIAL BASEPLATE, FEMORAL COMPONENT AND THE INSERT. ADDITIONALLY WAS OBSERVED THAT THERE WAS NO CEMENT ON THE BACK OF THE IMPLANT, INDICATING THAT THE PRODUCT HAD FAILED HAD THE CEMENT/IMPLANT INTERFACE. THE PATIENT IS ON EARLY STAGE OF RECOVERY.

  Patient problems: Failure of Implant; Laceration(s); Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 13022999 ↗
• InjuryNov 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED INSTABILITY ON STAIRS, IT WAS DETERMINED THAT THE PEG ON THE INSERT WAS BROKEN, BUT NO RELATED TRAUMA WAS REPORTED. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12813227 ↗
• MalfunctionMay 7, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKR, THE GII PS INSERT SZ 5-6 11MM WAS UNSTABLE ONCE PLACED BETWEEN THE FEMORAL AND TIBIAL COMPONENTS. THE AREA WAS CLEANED OFF BEFORE PLACING THE INSERT, AND THE INSERT WAS POSITIONED USING THE TIBIAL IMPACTOR, THIS WAS DONE MULTIPLE TIMES BUT THE INSERT CONTINUED TO BE UNSTABLE AND NOT FITTING PROPERLY. THE PROCEDURE WAS FINISHED USING A BACK-UP INSERT FROM SMITH AND NEPHEW, WHICH HAVE NO ISSUE ONCE POSITIONED. A DELAY OF LESS THAN OR EQUAL TO 30MINS WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794909 ↗
• MalfunctionMar 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TKA SURGERY, THE GENESIS II POSTERIOR STABILIZED INSERT SIZE 5-6 11MM COULD NOT BE LOCKED PROPERLY. PROCEDURE WAS FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT. 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 11541466 ↗
• MalfunctionDec 30, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE THE GII PS INSERT SZ 5-6 11MM WOULD NOT ENGAGE WITH THE TIBIAL BASEPLATE AFTER MULTIPLE ATTEMPTS. A BACKUP INSERT FROM THE SAME CONFIGURATION WAS USED, WHICH ENGAGED STRAIGHT AWAY. THERE WAS A DELAY OF LESS THAN 30 MIN. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094770 ↗
• MalfunctionDec 29, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, THE INLAY OF A GENESIS II PS INSERT SIZE 5-6 11MM COULD NOT BE INSERTED. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088817 ↗
• InjuryDec 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, A REVISION OF A GEN 2 TIBIA FROM APPROXIMATELY 2010 WAS PERFORMED. THE TIBIA INSERT WAS LOOSE AND REMOVED WITH FINGERS AND REVISED TO A LEGION REVISION TIBIA WITH STEM. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 11023501 ↗
• InjuryOct 15, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE POST OF A GII PS INSERT SZ 5-6 11MM BROKE. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10687653 ↗
• InjuryAug 5, 2020Break; Break

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT WAS FELL WHILE DOING THE GARDEN AND FELT A POP. AFTER, X-RAYS WERE PERFORMED TO CONFIRM THE STEM OF THE PS INSERT HAD SNAPPED FROM THE ORIGINAL IMPLANT. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10370524 ↗
• InjuryJun 23, 2020Break; Break

  IT WAS REPORTED THAT A POST BROKE OFF THE INSERT DURING USE INSIDE THE PATIENT. AL PIECES WERE REMOVED AND NOTHING WAS LEFT IN THE PATIENT. A NEW INSERT WAS USED TO FINISH THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10183222 ↗
• InjuryMar 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE ENTIRE SYSTEM WAS REPLACED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9856832 ↗
• MalfunctionAug 12, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY UPON PERFORMING MOBILITY AND EXTENSION TESTS ON THE IMPLANTED DEVICES, THE INSERT THROW AND FELL ON THE FLOOR. THIS HAPPENED SEVERAL TIMES SO THE DEVICE WAS COMPROMISED. A DELAY OF OVER 2 HOURS WAS REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE. TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882990 ↗
• MalfunctionMay 6, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE INSERT AND THE BASE PLATE DID NOT FIT WELL. A 30MIN-1HR DELAY WAS REPORTED. BACK UP AVAILABLE AND USED. NO MORE INFORMATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582573 ↗

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