Optetrak 208-22-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862054166), received between Jan 30, 2022 and Apr 28, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 106 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ASEPTIC LOOSENING, AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 21917606 ↗
• InjuryJan 27, 2025Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2009 AND THEN APPROXIMATELY 12 YEARS, 9 MONTHS LATER EXPERIENCED A SECOND KNEE REVISION ON (B)(6) 2022. PATIENT EXPERIENCED PROSTHESIS WEAR, FEMORAL LOOSENING, SYNOVITIS, OSTEOLYSIS AND PAIN. REVISION OPERATIVE REPORT 30 AUG 2022-PRELIMINARY DIAGNOSIS: 1. RECALLED RIGHT KNEE IMPLANT, 2. ASEPTIC LOOSENING RIGHT TOTAL KNEE REPLACEMENT. REVISION RIGHT TOTAL KNEE REPLACEMENT, ALL COMPONENTS. REVISION TO COMPETITOR¿S DEVICES. INDICATION- PATIENT HAD INTERMITTENT PAIN. MRI SHOWED SIGNIFICANT CONCERNING AREAS FOR LOOSING AND SYNOVITIS AS WELL AS AREAS OF OSTEOLYSIS. -THE FEMUR WAS NOTED TO BE GROSSLY LOOSE WITH GENTLY INTERRUPTION OF THE BONE CEMENT INTERFACE. THERE WAS TREMENDOUS GRADE TO A BONE LOSS OF THE PROXIMAL FEMUR WITH ALMOST COMPLETE LOSS OF THE LATERAL FEMORAL CONDYLE. DEBRIS WAS CLEANED AND A COMPLETE SYNOVECTOMY WAS PERFORMED. -THE TIBIA WAS NOTED TO BE WELL FIXED. IT WAS REMOVED. -THE PATELLA WAS EASILY REMOVED, THERE WAS SUBIMPLANT OSTEOLYSIS. NEW DEVICES WERE TRIALED AND THEN IMPLANTED. A STERILE COMPRESSIVE DRESSING WAS PLACED THE PATIENT AWAKENED TRANSFERRED TO THE RECOVERY ROOM TH

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

  MAUDE report 21246361 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2006, 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Failure of Implant; Implant Pain; Swelling/ Edema

  MAUDE report 19274664 ↗
• InjuryFeb 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 8 YEARS, 7 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023 - ASEPTIC REVISION LEFT TOTAL KNEE/ MECHANICAL LOOSENING OF INTERNAL LEFT KNEE PROSTHETIC JOINT. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. PATIENT HAD SIGNIFICANT PERIPROSTHETIC OSTEOLYSIS AND ASEPTIC LOOSENING WITH ASSOCIATED PAIN. PATIENT HAD SEVERE REACTIVE SYNOVITIS AND JOINT EFFUSION CONSISTENT WITH POLYETHYLENE WEAR AND COMPONENT LOOSENING. ON INSPECTION THE FEMORAL COMPONENT WAS NOT GROSSLY LOOSE, IT WAS REMOVED. THE TIBIAL COMPONENT WAS WELL FIXED, IT WAS REMOVED. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 18788706 ↗
• InjuryDec 28, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2007. THIS DEVICE HAS NOT BEEN EXPLANTED. 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: Adult Respiratory Distress Syndrome; Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 18408051 ↗
• InjuryAug 16, 2023Structural Problem; Device Dislodged or Dislocated; Naturally Worn; Structural Problem; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009 AND THEN APPROXIMATELY 8 MONTHS LATER HAD A SCREW USED TO SECURE THE POLYETHYLENE SPACER BACK OUT [THE SPINE STIFFENING SCREW, BACKED OUT OF THE INSERT] IT WAS REMOVED AND A NEW INSERT AND SCREW WERE PLACED. 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: Osteolysis; Pain; Synovitis

  MAUDE report 17556847 ↗
• InjuryMay 25, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON 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 208-22-09-INSERTO TIBIAL CC 2,9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 12/12/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 12/12/2011 AND WAS 1.19 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON( B)(6) 2018, APPROXIMATELY 5.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17001484 ↗
• InjuryMay 24, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON 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 208-22-09-INSERTO TIBIAL CC 2,9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 7/29/2013 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 7/29/2013 AND WAS 0.62 YEARS SHELF AGE AT THE TIME OF IMPLANT. PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17000018 ↗
• InjuryApr 17, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED VIA LEGAL THAT ON (B)(6) 2015, THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SURGERY. THE PATIENT EXPERIENCES PAIN IN HER RIGHT KNEE AND WILL LIKELY REQUIRE A REVISION SURGERY. 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: Implant Pain

  MAUDE report 16753273 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT THE PATIENT, WAS INITIALLY IMPLANTED WITH A RECALLED POLYETHYLENE TIBIAL INSERT IN HIS RIGHT KNEE, ON (B)(6) 2009. PATIENT WILL LIKELY BE REQUIRED TO UNDERGO SURGERY ON HIS RIGHT KNEE IN THE FORESEEABLE FUTURE. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICES AS DESCRIBED HEREIN, PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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 16524971 ↗
• InjuryJan 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL RIGHT TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Bacterial Infection

  MAUDE report 13390460 ↗

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-