GENESIS II 71421117Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010469311), received between Apr 25, 2018 and Jan 29, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE GII OXIN P/S FEM RIGHT SZ 7, THE SIZE 7 TIBIA AND THE 9MM INSERT WERE REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21264023 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY WAS PERFORMED ON (B)(6) 2014, IN WHICH A GII OXIN P/S FEM RIGHT SZ 7, A GNS II CEM TIB SIZE 8 RIGHT AND A GII PS HI FLEX ISRT SZ 7-8 11 WERE IMPLANTED, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN. THE PHYSICIAN DECIDED TO PERFORM AN ADDITIONAL SURGERY TO RESURFACE THE PATELLA ON (B)(6) 2024. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 18988571 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA WITH GII CONSTRUCTS WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED STIFFNESS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EFFECT. THE GII OXIN P/S FEM RIGHT SZ 7 (CASE: (B)(4)), THE GNS II CMT TIB SIZE 6 RIGHT (CASE: (B)(4)), AND THE GII PS INSERT SZ 5-6 9MM (CASE: (B)(4)) WERE EXPLANTED. IT IS UNKNOWN WHAT NEW DEVICES WERE IMPLANTED TO THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11821353 ↗
• MalfunctionNov 12, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. ALL PRIMARY IMPLANTS REMOVED EXCEPT FOR PATELLA. PATELLA LEFT INSITU. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309487 ↗
• InjuryOct 15, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. FEMORAL AND TIBIAL IMPLANT EXTRACTED. DELAY OF LESS THAN 30MIN REPORTED. BACK UP AVAILABLE.

  Patient problems: Injury; No Information; No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 7967795 ↗
• InjuryApr 25, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND INFECTION.

  Patient problems: Injury

  MAUDE report 7457305 ↗

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