Optetrak 244-23-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862064011), received between Sep 9, 2022 and Aug 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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, 2021Open, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 20 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19961082 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 181 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND BONE FRACTURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Failure of Implant; Implant Pain; Pain; Scar Tissue

  MAUDE report 19267502 ↗
• InjuryNov 9, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS FEMALE PATIENT WAS REVISED FOR A THIRD TIME IN (B)(6) 2021 (1ST REVISION: CASE-(B)(4) / 1038671-2023-02731, 2ND REVISION: CASE-(B)(4) / 1038671-2023-02728). POLYETHYLENE IS OBSERVED WITH WEAR IN THE MEDIAL AREA AND IN THE CENTRAL PIVOT, WITH MEDIAL AND POSTEROLATERAL DELAMINATION. REVISED TO A COMPETITOR DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18103795 ↗
• InjuryNov 10, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2013, DUE TO OSTEOARTHRITIS, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, APPROXIMATELY 8 YEARS 6 MONTHS POST THE INITIAL IMPLANT PROCEDURE DUE TO A FAILED RIGHT TOTAL KNEE ARTHROPLASTY WITH SEVERE PROXIMAL TIBIAL BONE LOSS SECONDARY TO OSTEOLYSIS. THE SURGEON¿S DICTATED INTRAOPERATIVE FINDINGS INDICATED THAT THERE WAS COPIOUS FIBRINOUS SCAR TISSUE HEMOSIDERIN STAINED SYNOVITIS, "AND"...SEGMENTED BONE LOSS FROM THE PROXIMAL TIBIA WAS NOTED FROM THE MEDICAL ASPECT OF THE TIBIAL TUBERCLE GOING AROUND COUNTER-CLOCKWISE TO THE LATERAL ASPECT OF THE TIBIAL TUBERCLE. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING, AND EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS RIGHT KNEE WHICH LIMITS HIS ACTIVITIES AND IMPACTS HIS QUALITY OF LIFE. NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Osteolysis; Osteopenia/ Osteoporosis; Pain; Scar Tissue; Synovitis

  MAUDE report 15770149 ↗
• InjuryOct 5, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2012. THE PATIENT WAS REVISED ON (B)(6) 2014, DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT, CAUSING LOOSE COMPONENTS AND OSTEOLYSIS. NO OTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15543692 ↗
• InjurySep 9, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2008, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 14 YEARS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

  Patient problems: Failure of Implant; Joint Impingement; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15394599 ↗

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