GENESIS II 71420524Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010208040), received between Dec 18, 2017 and Dec 2, 2025 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse 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) 2025, THE PATIENT BECAME SEPTIC AND INFECTION SPREAD TO THE KNEE. THIS ADVERSE EVENT WAS SOLVED BY REVISION INCISION AND DRAINAGE SURGERY ON (B)(6) 2025, IN WHICH THE GNSII CON INS SZ3-4 11MM WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 23700956 ↗
• InjuryOct 22, 2025Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE POLY DISASSOCIATED FROM BASEPLATE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) GNSII CON INS SZ3-4 11MM WAS EXCHANGED FOR A NEW POLY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23364261 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO INSTABILITY OF THE KNEE. DURING THE PROCEDURE, THE GNSII CON INS SZ3-4 11 MM WAS EXPLANTED AND REPLACED WITH A POLYETHYLENE INSERT OF THE SAME TYPE BUT UPSIZED TO 15 MM. A NON-SIGNIFICANT PROCEDURAL DELAY WAS NOTED. NO ADDITIONAL COMPLICATIONS OR ADVERSE OUTCOMES WERE REPORTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22661413 ↗
• InjuryJul 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER UNDERGOING A FIRST REVISION-TKA ON UNKNOWN DATE, PATIENT'S CONSTRAINED POLY UNLOCKED ITSELF FROM THE LEGION REVISION TIBIAL TRAY SIZE 3, RESULTING IN LOOSENING. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, THE GNSII CON INS SZ3-4 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19767971 ↗
• MalfunctionJun 11, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING THR SURGERY, THE GNSII CON INS SZ3-4 11MM WAS NOT LOCKED TO THE MEDICAL DEVICE DESPITE THE INTERVENTION OF THE EXPERIENCED TEAM. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510620 ↗
• MalfunctionOct 16, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GNSII CON INS SZ3-4 11MM AND THE TIBIAL BASEPLATE DID NOT FIT TOGETHER, MAKING THE PRODUCT UNUSABLE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30MINUTES, WITH A S+N BACKUP DEVICE. THE PATIENT REQUIRED ADDITIONAL ANESTHETIZATION DUE TO THE SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940837 ↗
• InjuryJun 10, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING TKA SURGERY, THERE WAS A GAP BETWEEN THE GNSII CON INS SZ3-4 11MM AND THE BASEPLATE. THE PROCEDURE COULD NOT BE COMPLETED. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977676 ↗
• MalfunctionFeb 21, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE ARTICULAR INSERT WOULD NOT ¿SNAP IN¿ TO TIBIAL BASE PLATE AN KEPT POPPING OUT DURING MANIPULATION. AFTER SEVERAL ATTEMPTS SURGEON WAS GIVEN A BACK UP INSERT FROM SMITH AND NEPHEW WHICH WORKED CORRECTLY. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356717 ↗
• MalfunctionJan 14, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING GII KNEE SURGERY, THE INSERT AND THE TIBIAL BASEPLATE DID NOT FIT TOGETHER AND THERE WAS A GAP IN THE MIDDLE, MAKING THE PRODUCT UNUSABLE. FINALLY, A S+N BACKUP OF THE INSERT WAS USED TO COMPLETE THE SURGERY. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11169240 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORM ON AUG 31,2020 DUE TO JOINT LIGAMENT LAXITY. THE PRIMARY TOTAL KNEE ARTHROPLASTY PROCEDURE WAS APPROXIMATELY 10 YEARS AGO. NO MORE INFORMATION AVAILABLE.

  Patient problems: Damage to Ligament(s); Extraskeletal ossification; Injury; Joint Laxity; Scar Tissue

  MAUDE report 10591551 ↗
• MalfunctionSep 23, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE GII INSERT COULD NOT SEAT PROPERLY, CAUSING LATERALLY DISENGAGE REPEATEDLY; THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10574938 ↗
• InjuryFeb 14, 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 DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 9713248 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 9255856 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL PARTS WERE REMOVED AND REPLACED WITH CEMENT MOULDS FROM HERAEUS. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9073015 ↗
• InjuryDec 18, 2017Break; Break

  REVISION ON LEGION INSERT DUE TO UNDERSIDE LOCKING MECHANISM BREAKING AND POLY DISLOCATING.

  Patient problems: Joint Dislocation

  MAUDE report 7127412 ↗

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