Optetrak Logic 02-012-48-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862159298), received between Apr 26, 2022 and Jul 18, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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

1 other recall cover devices cleared under the same FDA submission (K111400); they may or may not involve this specific model.

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

• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS; NEGATIVELY IMPACTED MOBILITY AND QUALITY OF LIFE, REVISION SURGERY; RESULTANT PAIN FOLLOWING SURGERY AND RECUPERATION/REHABILITATION PERIOD AND PHYSICAL THERAPY; ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 19774410 ↗
• InjuryApr 24, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN WAS REVISED ON AN UNKNOWN DATE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19171941 ↗
• InjuryAug 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2016. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 5 YEARS 10 MONTHS POST PRIMARY PROCEDURE. PREOPERATIVE CT SCAN REFLECTING OSTEOLYTIC CHANGE, WAS SMALL AND WITH MAINTENANCE OF INTEGRITY OF THE IMPLANT FIXATION. BECAUSE A WELL-FIXED IMPLANT, LUCENCY IS SMALL AND FUSION CONSISTENT WITH SYNOVITIS FROM POLYETHYLENE DEBRIS. REVISION OP REPORT NOTED THE POLYETHYLENE HAD SOME PITTING AND DEGRADATION. THERE WAS NO METALOSIS PRESENT. THE SURGEON NOTED THE POLYETHYLENE OF THE PATELLA APPEARED TO BE PRISTINE WITHOUT PATHOLOGY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 17652658 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY THREE YEARS POST INITIAL TKA, THIS (B)(6) MALE PATIENT UNDERWENT A REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14210872 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013