Optetrak 208-24-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862054326), received between Feb 1, 2022 and Jun 10, 2025 — classified as 9 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.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 13 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, STIFFNESS, LOSS OF MOTION, WEAKNESS, AND DIFFICULTY AMBULATING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 22179191 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING INVESTIGATION OF A REPORTED REVISION FOR THIS MALE PATIENT, THAT AN EARLIER REVISION WAS FOUND. THE MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2008, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014, APPROXIMATELY 5 YEARS 7 MONTHS POST THE INITIAL PROCEDURE FOR REASONS UNKNOWN. 2ND REVISION REPORTED UNDER MDR # 1038671-2022-01100.

  Patient problems: Insufficient Information

  MAUDE report 18522611 ↗
• InjuryJul 31, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2009. APPROXIMATELY 11 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2020. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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: Discomfort; Insufficient Information; Joint effusion; Muscle Weakness/Atrophy; Osteolysis; Synovitis

  MAUDE report 17426021 ↗
• InjuryFeb 27, 2023Naturally Worn; Naturally Worn

  57 Y/O FEMALE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO PAIN, SWELLING AND STIFFNESS. THIS IS APPROXIMATELY 5 YEARS AND 11 MONTHS AFTER THE PATIENT'S INITIAL RIGHT KNEE REPLACEMENT. IMAGING STUDIES DEMONSTRATE PARTICULATE DEBRIS-INDUCED SYNOVITIS. THERE IS NO EXTENSIVE OSTEOLYSIS BASED ON PREOPERATIVE IMAGING. THE PATIENT HAS PERSISTENT PAIN AND SWELLING AND IS THUS INDICATED FOR POLYETHYLENE LINER EXCHANGE. FINDINGS: AT THE TIME OF SURGERY, THERE WAS FOUND TO BE AN EFFUSION. THESE WAS MODERATELY INFLAMED SYNOVIUM. THERE WERE NO SIGNS OF INFECTION. FEMORAL, TIBIAL AND PATELLAR COMPONENTS WERE ALL WELL FIXED. THERE WAS EXTENSIVE PSEUDOMEMBRANE AND SCAR FORMATION. THE PATIENT WAS BROUGHT TO RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 16448625 ↗
• InjurySep 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2010 AND WAS REVISED ON (B)(6) 2019 DUE TO UNKNOWN REASONS. NO OTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15492163 ↗
• InjurySep 13, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD LOGIC CC IMPLANTED IN THEIR RIGHT KNEE ON (B)(6) 2008, WAS REVISED ON (B)(6) 2022, APPROXIMATELY 14 YEARS 1 MONTH POST THE INITIAL IMPLANT PROCEDURE DUE TO EXCESSIVE WEAR TO THE IMPLANTS. REVISION TO LOGIC CC SYSTEM WENT EXTREMELY WELL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413174 ↗
• InjuryAug 31, 2022Peeled/Delaminated; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL, THAT THIS PATIENT'S RIGHT KNEE WAS IMPLANTED (B)(6) 2005; REVISION DATE: (B)(6) 2019. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Cyst(s); Discomfort; Insufficient Information; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15331666 ↗
• InjuryFeb 2, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWENTY YEARS POST INITIAL LEFT SIDE TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING AND OSTEOLYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13423822 ↗
• InjuryFeb 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6.13 YEARS SINCE INITIAL IMPLANT, THIS MALE PATIENT WITH BMI 30.8 UNDERWENT LEFT SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL #: (B)(4). ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY AND POLYETHYLENE WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Failure of Implant

  MAUDE report 13413500 ↗

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-