Optetrak Logic 02-012-49-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862159229), received between Jun 28, 2022 and Mar 5, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Naturally Worn; Lack of Effect

  THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. THE PATIENT LATER PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, STIFFNESS, DECREASED RANGE OF MOTION, AND OVERALL DISSATISFACTION WITH THE KNEE REPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT REVISION SURGERY CONSISTING OF A TIBIAL POLYETHYLENE INSERT AND PATELLAR COMPONENT EXCHANGE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 24524916 ↗
• InjuryMay 6, 2025Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED BACK TO THE SURGEON'S OFFICE WITH CONCERNS OF A RECALLED IMPLANT, ALONG WITH PAIN, INSTABILITY, AND DISSATISFACTION. THE INSERT WAS REVISED TO A NEW INSERT. POSTERIOR ASPECTS OF THE POLYETHYLENE WAS BROKEN IN PIECES, AND THE PIECES OF POLYETHYLENE WERE REMOVED. THE KNEE JOINT WAS IRRIGATED WELL. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21967793 ↗
• InjuryMar 6, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; 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) 2023 APPROXIMATELY 5 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Cyst(s); Failure of Implant; Implant Pain; Joint effusion; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 18844340 ↗
• InjuryJun 21, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON AN UNKNOWN DATE. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY AND DISSATISFACTION WITH THEIR LEFT TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION THE PATIENT WAS SCHEDULED FOR HAVE A REVISION TKA POSSIBLE POLY SWAP VS. A COMPLETE REVISION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE PATIENT UNDERWENT A FULL KNEE REVISION AND WAS REVISED WITH A DIFFERENT COMPANY'S KNEE SYSTEM.

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

  MAUDE report 17177518 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2016. PATIENT'S IS SCHEDULED TO UNDERGO REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022 DUE TO CLAIMS OF PREMATURE FAILURE OF HER EXACTECH OPTETRAK TOTAL KNEE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 14838900 ↗

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