Optetrak 208-25-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862054449), received between Feb 4, 2022 and Sep 18, 2024 — classified as 4 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.

1 other recall cover devices cleared under the same FDA submission (K954208); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 93 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAINFUL LEFT KNEE REPLACEMENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20245540 ↗
• InjuryMar 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 74 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2002, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 21 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE POLY WORE OVER TIME. THE PATIENT WAS REVISED TO A 208-25-22 CC TIBIAL INSERT SZ 5 22MM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. THE HOSPITAL KEPT THE DEVICES. NO DEVICE IMAGES OR X-RAYS WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18881873 ↗
• InjuryMar 13, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION-PREOPERATIVELY THE PATIENT HAD FLEXION CONTRACTURE AND LACK OF FULL FLEXION. HOSPITAL CARE TIME: ADMITTED (B)(6) 2023 AND DISCHARGED (B)(6) 2023. PATIENT WAS REVISED TO AN EXACTECH OPTETRAK INSERT. 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; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 16533928 ↗
• InjuryFeb 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9.68 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 32.1 UNDERWENT A RIGHT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Failure of Implant

  MAUDE report 13450443 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-