Optetrak 204-36-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862048936), received between Dec 9, 2024 and Dec 9, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Fracture; Fracture

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015, AND THEN EXPERIENCED A SECOND REVISION SURGICAL PROCEDURE ON (B)(6) 2016, APPROXIMATELY 11 MONTHS AFTER REVISION SURGERY. THE PATIENT EXPERIENCED OSTEOLYSIS, AMBULATION OR POSTURAL DIFFICULTIES, SWELLING/ EDEMA, PAIN, FAILURE OF IMPLANT, BALANCE PROBLEMS AND DISCOMFORT. SURGEON WAS PERFORMING REVISION RIGHT TOTAL KNEE ARTHROPLASTY FOR WHAT WAS THOUGHT TO BE AN ASEPTICALLY LOOSE TIBIAL COMPONENT S/P REV RT TKA ON (B)(6) 2015. THE TIBIA APPEARED AND WAS FOUND TO BE WELL FIXED. THE FEMORAL COMPONENT, HOWEVER, WAS MANUALLY PUSHED ON BY THE SURGEON AND WAS NOTED TO BE LOOSE WHEN FLUID OOZED OUT THE SIDES FROM THE UNDERSIDE OF THE FEMORAL COMPONENT. THE SURGEON WENT TO THEN REMOVE THE FEMUR BY USING THE LOCKING FEMORAL HANDLE AND SLAP HAMMER AND THE FEMUR EASILY CAME OFF WITH ONE SLAP OF THE SLAP HAMMER. THE SURGEON IMMEDIATELY NOTICED THAT THE CC FEMORAL COMPONENT HAD COME OFF BUT THE STEM EXTENSION WAS NOT ATTACHED TO IT. THE FEMORAL STEM EXTENSION WAS STILL IN THE FEMORAL CANAL. GRAY METALLIC DEBRIS WAS NOTED ON THE FEMUR. A SCREW REMOVAL SYSTEM WAS USED TO EXTRACT THE STEM EXTENSION, IN W

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20879885 ↗