GENESIS II 71422050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010496324), received between Mar 25, 2019 and Feb 2, 2022 — classified as 2 injuries, 1 malfunction.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED TRAUMA TO FEMUR. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GII C/R HA POROUS FEM SZ 7LT WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13423420 ↗
• MalfunctionJul 29, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING THE PROCEDURE OF BILATERAL TKR THE IMPLANT WAS SCRATCH. THE SURGEON HAD THE OPTION OF PLACING A THE OXONIUM IMPLANT (BACKUP FROM SMITH+NEPHEW), BUT IT DECIDED TO FINISH THE PROCEDURE WITH THE IMPLANT SCRATCHED. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10339303 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT AND METALLOSIS WAS FOUND AS THE CAUSE OF PAIN. NO INFECTION PRESENT. TWO DEVICES REPORTED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Pain

  MAUDE report 8448818 ↗