Optetrak Logic 02-010-04-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862158277), received between Mar 27, 2024 and Dec 4, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 7 YEARS 9 MONTHS POST THE INITIAL LEFT KNEE IMPLANTATION, IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS REVISED DUE TO FEMUR LOOSENING, OSTEOLYSIS AND POLY WEAR. ALL COMPONENTS WERE REMOVED AND WERE REPLACED BY A COMPETITOR¿S REVISION KNEE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THEY WERE DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 20844665 ↗
• InjuryMar 27, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 1 YEAR, 9 MONTHS LATER ON (B)(6) 2022 THE PATIENT EXPERIENCED A REVISION SURGICAL PROCEDURE. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. REVISION OPERATIVE REPORT OF 26 APR 2022- FAILED TKA SECONDARY SEPTIC LOOSENING. X-RAYS DEMONSTRATED LOOSENING OF TIBIAL AS WELL AS PATELLAR COMPONENT. ASPIRATED KNEE, IT WAS SIGNIFICANT FOR RED BLOOD CELLS AS WELL AS 12,000 WHITE BLOOD CELLS WITH 100% NEUTROPHIL DIFFERENTIAL- NOTHING GREW FROM THE ASPIRATION. PATELLAR COMPONENT WAS COMPLETELY LOOSE. REMOVED ANY REMAINING CEMENT. FEMORAL COMPONENT WAS GROSSLY LOOSE. REMOVED IT AS WELL AS THE FIBROUS TISSUE UNDERNEATH IT ALL THE WAY BACK TO BONE. REMOVED THE TIBIAL COMPONENT, IT WAS GROSSLY LOOSE. STERILE DRESSING WAS APPLIED. NO APPARENT COMPLICATIONS NOTED. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Inadequate Osseointegration; Inflammation; Joint Laxity; Pain; Unspecified Infection

  MAUDE report 18988700 ↗