Optetrak 244-25-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862064080), received between Oct 29, 2019 and Sep 6, 2023 — classified as 3 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.

3 other recalls cover devices cleared under the same FDA submission (K033883); 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 16, 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-0019-2022 · 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.

• InjurySep 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2007. APPROXIMATELY 15 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES: PAIN, SUFFERING, AND INSTABILITY IN HIS LEFT KNEE. THE COMPONENTS OF HIS IMPLANT WERE NOTED TO BE GROSSLY LOOSE AND WERE REPLACED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. 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 ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A S

  Patient problems: Failure of Implant

  MAUDE report 17691058 ↗
• InjuryFeb 24, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, INITIAL UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2014 AND WAS IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING AN OPTETRAK HI-FLEX PS TIBIAL INSERT, 11 MM MADE OF POLYETHYLENE. PLAINTIFF UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2022, APPROXIMATELY 7 YEARS 11 MONTHS POST INITIAL PROCEDURE. UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS AND OSTEOLYSIS IN PLAINTIFF'S RIGHT KNEE WAS DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING. DESPITE UNDERGOING REVISION SURGERY, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 16433722 ↗
• InjuryOct 29, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY WAS (B)(6) 2009. WORN POLY, FAILED PATELLA COMPONENT. REMOVED PATELLA, REPLACED TIBIAL BASEPLATE WITH A STEMMED COMPONENT AND NEW INSERT.

  Patient problems: Fall; No Information

  MAUDE report 9250383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inser
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants