GENESIS II 71421519Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010493835), received between Jul 24, 2018 and Nov 4, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2015 DUE TO PATELLA MALTRACKING. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,46 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INSTABILITY THAT REQUIRED A TKA RE-REVISION. AN UNSPECIFIED TIBIAL COMPONENT AND GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 5-6 18MM WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 20601803 ↗
• InjuryNov 25, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT REPORTED ONGOING PAIN. PATIENT WAS SENT FOR A BONE SCAN THAT SHOWED AN AREA OF CONCERN MEDIALLY UNDER THE TIBIAL BASEPLATE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH IT WAS FOUND THAT THE TISSUES HAD THE TYPICAL APPEARANCE OF METALLOSIS, WITH INFLAMED SYNOVIUM AND FLUID COLLECTION. TISSUE SAMPLES AND RETRIEVED IMPLANTS WERE SENT FOR PATHOLOGY TESTING. VISUAL INSPECTION OF IMPLANTS SHOWED WEAR ON THE POSTERIOR SIDE OF THE GII PS HI FLEX ISRT SZ 5-6 18. NIL WEAR WAS VISIBLE TO GII NONPOROUS P/S FEM SZ 6 LT NOR GNS II CMT TIB SIZE 6 LEFT. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 12875261 ↗
• InjuryDec 12, 2018Adverse 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 RIGHT KNEE INSTABILITY STATUS POST TOTAL KNEE REPLACEMENT. TIBIAL COMPONENT, TIBIAL BASEPLATE AND POLY INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 8157023 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DIAGNOSED WITH RIGHT KNEE STIFFNESS STATUS POST REVISION, AND RIGHT KNEE REPLACEMENT. A MANIPULATION UNDER ANESTHESIA AND AN INJECTION OF PAIN COCKTAIL CONTAINING TORADOL, MORPHINE, EPINEPHRINE AND BUPIVACAINE, IN PERIARTICULAR TISSUES AND INTRA-ARTICULARLY WERE PERFORMED.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8155813 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8155216 ↗
• InjurySep 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY FO RIGHT KNEE WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7846484 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR DID A POLY EXCHANGE, DUE TO A SUSPECTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7716755 ↗

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-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-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-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
• 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-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-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