Optetrak 208-22-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862054197), received between May 6, 2022 and Dec 30, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL KNEE REVISION REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037110 ↗
• InjuryNov 8, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 8 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND CLICKING. INITIAL SURGERY AND 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: Insufficient Information; Pain; Scar Tissue

  MAUDE report 20641914 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 137 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19567478 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19347430 ↗
• InjuryMay 14, 2024Mechanical Problem; Detachment of Device or Device Component; Naturally Worn; Mechanical Problem; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF LEFT KNEE TOTAL KNEE ARTHROPLASTY PROSTHESIS WITH LOOSE COMPONENTS; CORTICAL FRACTURE OF LEFT FEMUR; SEVERE OSTEOLYSIS, LOSS OF RANGE OF MOTION; CHRONIC PAIN; INJURIES TO TISSUE AND CONE OF THE LEFT KNEE; SUBCHONDRAL CYST; JOINT EFFUSION; METALLOSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Cyst(s); Failure of Implant; Implant Pain; Joint effusion; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 19314799 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 101 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A FUTURE REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. THE PATIENT HAS REPORTED MENTAL ANGUISH AND AGONY, PAIN, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19285299 ↗
• InjuryJul 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE SURGERY ON (B)(6)2013. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6)2022, APPROXIMATELY 9 YEARS 6 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6)2022 OP REPORT INDICATIONS: THE PATIENT IS S/P RIGHT KNEE REPLACEMENT WITH AN EXACTECH KNEE. THE TIBIAL COMPONENT LOOSENED AND WAS REVISED. MOST RECENTLY SHE RETURNED WITH NEW INCREASED PAIN WITH WEIGHTBEARING. MRI DEMONSTRATED LARGE AREAS OF OSTEOLYSIS ABOUT THE ANTERIOR FLANGE AND THE POSTERIOR FLANGE OF THE FEMORAL COMPONENT. THE TIBIAL COMPONENT DEMONSTRATES CIRCUMFERENTIAL RESORPTION ABOUT THE CEMENT MANTLE OF THE TRAY EXTENDING ALONG THE PROXIMAL KEEL. THE SURGEON ALSO NOTED THAT THE FEMORAL COMPONENT WAS WELL FIXED BUT THERE WERE NOTED TO BE LARGE LYTIC AREAS WHEN PROBED, AND THAT THE PATELLA WAS GROSSLY LOOSE AND REMOVED WITH LITTLE DIFFICULTY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO RECOVERY UNIT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 17274371 ↗
• InjuryMay 21, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6), WAS IMPLANTED WITH A 208-22-15-INSERTO TIBIAL CC 2,15MM, SERIAL NUMBER (B)(6), ON (B)(6) 2017. THE INSERT WAS MANUFACTURED ON (B)(6) 2013, AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2013, AND WAS 3.7 YEARS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY SIX YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Failure of Implant

  MAUDE report 16971210 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT LEFT TOTAL KNEE REVISION SURGERY DUE TO A ¿LEFT KNEE ASEPTIC LOOSENING" ON (B)(6) 2017. UPON REMOVAL OF THE ORIGINAL TIBIAL INSERT, PLAINTIFF WAS IMPLANTED WITH A SECOND RECALLED OPTETRAK DEVICE IN HER LEFT KNEE. PLAINTIFF¿S REVISION SURGERY WAS DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE DEFECTIVE POLYETHYLENE INSERT COMPONENT WITHIN THE OPTETRAK DEVICE. FOLLOWING HER REVISION SURGERY, PLAINTIFF CONTINUED TO EXPERIENCE PAIN IN HER LEFT KNEE, AND PLAINTIFF WILL BE PROCEEDING WITH A RE-REVISION SURGERY TO REMOVE THE SECOND RECALLED OPTETRAK DEVICE IMPLANTED IN HER LEFT KNEE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Erosion; Implant Pain; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16459655 ↗
• InjuryJan 23, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL TEAM, IN 2006, PATIENT SOUGHT TREATMENT FOR KNEE PAIN. AT THE RECOMMENDATION OF THE ORTHOPEDIC SURGEON, SHE UNDERWENT KNEE REPLACEMENT SURGERY ON HER RIGHT KNEE WITH AN OPTETRAK KNEE REPLACEMENT SYSTEM, INCLUDING THE DEFECTIVE INSERT AND DEFECTIVE TIBIAL TRAY. IN 2008, LESS THAN TWO YEARS AFTER HER KNEE REPLACEMENT SURGERY, PATIENT DEVELOPED LOOSENING OF THE DEVICE AND PAIN IN HER RIGHT KNEE. ON (B)(6) 2008, PATIENT UNDERWENT A SURGICAL REVISION OF HER RIGHT KNEE DUE TO "FAILED RIGHT KNEE WITH A LOOSE TIBIAL COMPONENT". AT THE TIME OF SURGERY, IT WAS DISCOVERED THAT PATIENT RIGHT KNEE WAS ALSO INFECTED AND, THEREFORE, THE OPTETRAK KNEE REPLACEMENT SYSTEM AND ITS COMPONENTS WERE REMOVED WHILE PATIENT UNDERWENT TREATMENT FOR THE INFECTION. PATIENT CONTINUED TREATMENT FOR THE INFECTION UNTIL (B)(6) 2009, WHEN ANOTHER OPTETRAK KNEE REPLACEMENT SYSTEM WAS IMPLANTED IN HER RIGHT KNEE, ALONG WITH ANOTHER DEFECTIVE INSERT. AT THAT TIME, UNBEKNOWNST TO PATIENT, PATIENT CONTINUED TO HAVE PAIN AND INSTABILITY IN CONNECTION WITH HER OPTETRAK KNEE REPLACEMENT SYSTEM AND, IN (B)(6) 2012, IT WAS DETERMINED THAT THE DEVICE HAD AGAIN LOOSENED AND FAILED, AND THAT, THEREFORE

  Patient problems: Failure of Implant; Osteolysis; Perforation of Vessels

  MAUDE report 16225409 ↗
• InjuryDec 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL THAT ON (B)(6) 2011, A FEMALE PATIENT UNDERWENT A LEFT TKR WITH AN OPTETRAK TIBIAL INSERT. APPROXIMATELY APRIL THE PATIENT NOTICED A ¿SQUEAK¿ IN HER RIGHT KNEE, AND SHE BEGAN EXPERIENCING INTERMITTENT DULL PAIN AND ACHING IN THAT JOINT. HER SYMPTOMS PROGRESSIVELY WORSENED, BUT THE PAIN REMAINED MODERATE AND WAS TREATABLE WITH ANTI-INFLAMMATORIES. IN (B)(6) 2019, THE PATIENT FELL AT WORK, CAUSING INCREASED PAIN, STIFFNESS, AND WEAKNESS IN HER RIGHT KNEE. ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF HER RIGHT OPTETRAK DEVICE. UPON EXPLANTATION OF THE OPTETRAK DEVICE, THE SURGEON OBSERVED THAT THERE WAS A ¿TREMENDOUS AMOUNT¿ OF SYNOVITIC MATERIAL AND INFLAMMATION CONSISTENT WITH POLYETHYLENE WEAR. THE COMPONENTS OF THE OPTETRAK DEVICE WERE LOOSE, AND SOME WERE REMOVABLE WITHOUT THE USE OF ANY INSTRUMENTS. NO ADDITIONAL INFORMATION.

  Patient problems: Fall

  MAUDE report 15912334 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY TWO YEARS POST LEFT TKA REVISION, PATIENT RETURNED TO SURGEON BECAUSE HER KNEE DIDN¿T FEEL RIGHT, AND SHE HAD SEVERE PAIN, PROBLEMS WITH HER MOBILITY, AND HAD TO BE IN A WHEELCHAIR SINCE 2013.

  Patient problems: Pain

  MAUDE report 14307907 ↗

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-