Optetrak Logic 02-012-35-4017Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862247414), received between Mar 21, 2023 and Oct 27, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryOct 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA AN EXPERIENCE REPORT, A CC CLINICAL STUDY, AND THROUGH LEGAL NOTIFICATION, THAT A 64 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2018, WITH A PATELLAR SLEEVE FRACTURE THAT PRESENTS AS CLICKING LATERALLY WITH FLEXION BUT IS NOT PAINFUL. INDICATION FOR REVISION SURGERY STATED ASEPTIC LOOSENING, INSTABILITY, AND PAIN/STIFFNESS. DATE OF ONSET WAS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENTS FOR A LOGIC CC KNEE. THE FEMORAL COMPONENTS WERE LOOSE. THE TIBIAL COMPONENTS WERE WELL FIXED. THE STUDY INDICATES THE EVENT IS POSSIBLY RELATED TO THE DEVICES AND THE PROCEDURE. THE FEMORAL, PATELLA, TIBIAL INSERT AND TRAY COMPONENTS WERE REVISED. THE STUDY INDICATES THE EVENT WAS RESOLVED ON THE SURGERY DATE. NO DEVICE RETURNED DUE TO CLINICAL STUDY GUIDELINES. THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHY

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 20541500 ↗
• InjuryMar 21, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2021, APPROXIMATELY 3 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Balance Problems; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 18955559 ↗
• InjuryMar 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 60 YO MALE PATIENT EXPERIENCED A PATELLAR SLEEVE FRACTURE WHICH PRESENTS AS CLICKING LATERALLY WITH FLEXION BUT IS NOT PAINFUL. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2018. THE PATIENT WAS REVISED ON (B)(6) 2022 WITH THE OUTCOME LAST KNOWN AS RESOLVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 16587654 ↗