GENESIS II 71421502Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010492340), received between May 5, 2017 and Dec 29, 2020 — classified as 7 injuries, 1 malfunction.

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 (K032295); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 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 DISLOCATION BETWEEN THE FEMORAL COMPONENT AND THE INSERT. THE DOCTOR SAYS THAT THE INSERT HAD EXCESSIVE WEAR.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11091553 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF GEN II WAS PERFORMED DUE TO AN UNSPECIFIED REASON. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 11018617 ↗
• MalfunctionDec 5, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED DURING THE ARTHROSCOPY PROCEDURE THAT THE GENESIS PE COULD NOT BE INSERTED. THE INCIDENT OCCURRED INSIDE THE PATIENT. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN AND IT WAS NECESSARY TO USE A BACKUP FROM SMITH & NEPHEW. ALTHOUGH THE SURGEON BLAMES THE DEVICE, HE WAS SATISFIED WITH THE SURGICAL OUTCOME. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10953269 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO THE INFECTION AND LOOSENING. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 AND GII FEM COMPONENT(71420052), GII TIB BASE (71420180), LEGION INSERT (71453202), PATELLA (71420580). ALL OF THE IMPLANTED DEVICES WERE REVISED. THE REVISED DEVICES WILL NOT BE RETURNED. THE DOCTOR DOES NOT CONSIDER AS THE FAILURE OF DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 9356863 ↗
• InjuryNov 20, 2018Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 8092455 ↗
• InjuryFeb 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO GONARTHROSIS AND INSTABILITY IN KNEE.

  Patient problems: Injury

  MAUDE report 7264266 ↗
• InjuryAug 2, 2017Difficult to Insert

  IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY, THE INSERT COULD NOT BE IMPACTED INTO TIBIAL TRAY AFTER SEVERAL ATEMPTS. FINALY A SAME MODEL BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUTH ISSUES, BUT CAUSING SIGNIFICANT SURGICAL DEALY.

  Patient problems: No Code Available

  MAUDE report 6759469 ↗
• InjuryMay 5, 2017Failure To Adhere Or Bond; Connection Problem; Device-Device Incompatibility; Failure To Adhere Or Bond; Device-Device Incompatibility

  IT WAS REPORTED THAT A KNEE REPLACEMENT SURGERY WAS EXTENDED FOR ONE HOUR DUE TO MULTIPLE ATTEMPTS TO STEADY LOCK THE INSERT INTO THE BASEPLATE. A BACK-UP INSERT WAS GIVEN WHICH LOCKED IN SUCCESSFULLY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6547008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295. One submission often covers many models, so check the product and lot details in each record.

• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic