Optetrak 208-24-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862054333), received between Feb 4, 2022 and Sep 16, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 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-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20226230 ↗
• InjurySep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 144 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, EFFUSION, CYST AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Cyst(s); Joint effusion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20225734 ↗
• InjuryJul 21, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6)2014. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6)2022, APPROXIMATELY 8 YEARS POST PRIMARY PROCEDURE. THE PATIENT HAS CLAIMS TO HAVE SUFFERED GRIEVOUS PAIN. 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.

  Patient problems: Pain

  MAUDE report 17372157 ↗
• InjuryApr 25, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2008, THIS PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK CC POLYETHYLENE TIBIAL INSERT. PATIENT EXPERIENCES PAIN IN HIS RIGHT KNEE AND MAY REQUIRE A RIGHT KNEE REVISION SURGERY TO REMOVE THE REMAINING RECALLED LINER AT A LATER TIME. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON A 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.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Erosion; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 16810385 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST PATIENT'S REVISION, THE MALE PATIENT HAD A SECOND REVISION FOR POLY SWAP. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15588468 ↗
• InjurySep 25, 2022Unstable; Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, A PATIENT HAD AN INITIAL LEFT KNEE REPLACEMENT SYSTEM ON 2 AUG 2010 AND WAS REVISED ON 6 MAY 2019. NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Erosion; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15481976 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 11.60 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 23.8 UNDERWENT A LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION DUE TO OSTEOLYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Osteolysis

  MAUDE report 13451401 ↗

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-