GENESIS II 71420628Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010208569), received between Aug 6, 2018 and May 18, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RECON SURGERY HAD BEEN PERFORMED, THE PATIENT REPORTED AN INFECTION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE LGN CR HIGH FLEX XLPE SZ 5-6 10MM, GII LNG STEM 10MM X 100MM, GNS II CMT TIB SIZE 6 LEFT, LEGION CR NP FEM SZ 6 LT, AND GNS II RESURF PAT 35MM. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 11843486 ↗
• InjuryJun 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, SURGEON HAS HAD FRACTURED TIBIA BONES DURING TWO SEPARATE SURGERIES WHILE IMPLANTING GENESIS II 100 MM TIBIA STEM. FURTHER INFORMATION IS UNKNOWN YET.

  Patient problems: Injury

  MAUDE report 8681315 ↗
• InjuryJun 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, SURGEON HAS HAD FRACTURED TIBIA BONES DURING TWO SEPARATE SURGERIES WHILE IMPLANTING GENESIS II 100 MM TIBIA STEM. FURTHER INFORMATION IS UNKNOWN YET.

  Patient problems: Injury

  MAUDE report 8681313 ↗
• InjuryAug 6, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT'S IMPLANT HAS CAUSED THE PATIENT A LOT OF PAIN AND PROSTHETIC JOINT MECHANICAL FAILURE. PATIENT IS WAITING ON APPOINTMENT FOR REVISION SURGERY TO REMOVE ALL DEVICES.

  Patient problems: Injury

  MAUDE report 7754764 ↗