GENESIS II 71421016Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010469229), received between May 14, 2018 and May 10, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K022010, K962557); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT PRESENTED STIFFNESS. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE GNS II CMT TIB SIZE 5 LEFT (CASE-(B)(4)), GII OXIN P/S FEM LEFT SZ 6 (CASE-(B)(4)) AND LGN PS HIGH FLEX XLPE SZ 5-6 9MM (CASE-(B)(4)). THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11797672 ↗
• InjuryJan 13, 2021Adverse 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, THE PATIENT PRESENTED TO THE HOSPITAL WITH A PSYCHIATRIC ILLNESS. DURING THE EVALUATION, THE LEFT KNEE AND LEFT LEG WERE FOUND TO BE SWOLLEN AND PAINFUL PROXIMALLY. THE LEFT KNEE WAS ASPIRATED AND FOUND TO HAVE VISIBLE PUS, SO THE PATIENT WAS BOOKED FOR REVISION OF THE FIRST STAGE OF THE LEFT KNEE ARTHROPLASTY AND REMOVAL OF ALL HARDWARE. A REVISION SURGERY WAS PERFORMED TO REMOVE ALL PROSTHESES AND INSERT AN ANTIBIOTIC SPACER. AFTER REMOVAL OF THE PROSTHESIS, PUS WAS VISUALIZED IN THE TIBIAL AND FEMORAL CANALS, LAVAGE WAS PERFORMED, AND A SPACER WAS INSERTED.

  Patient problems: Bacterial Infection; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 11167461 ↗
• InjuryAug 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED A REVISION SURGERY PERFORMED DUE TO PERSISTENT PAIN AND STIFFNESS. INSERT SIZE INCREASED TO SIZE 12. NEW 29 MM BICONVEX PATELLA IMPLANTED.

  Patient problems: Injury

  MAUDE report 8940105 ↗
• InjuryNov 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 1ST STAGE REVISION OF A GENESIS II TKR FROM 2004 WAS PERFORMED. IT WAS REVISED DUE TO INFECTION. EARLY THIS YEAR, THE KNEE WAS WASHED OUT, AND THE POLYETHYLENE WAS REVISED IN AN ATTEMPT TO CLEAR THE INFECTION. THIS WAS ULTIMATELY UNSUCCESSFUL. ORIGINAL OP NOTES ARE NOT AVAILABLE, SO LOT NUMBERS ETC ARE UNAVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8034895 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT TWISTED HIS KNEE AND DEVELOPED BLEEDING. AN ASPIRATION WAS PERFORMED WITH ONLY ANTI-INFLAMMATORY MEDICATION.

  Patient problems: Injury

  MAUDE report 7509853 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT TWISTED HIS KNEE AND DEVELOPED BLEEDING. AN ASPIRATION WAS PERFORMED WITH ONLY ANTI-INFLAMMATORY MEDICATION.

  Patient problems: Injury

  MAUDE report 7509851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022010, K962557. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic