Optetrak 208-23-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862054258), received between Mar 2, 2023 and Aug 15, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY DUE TO OSTEOARTHRITIS. THEY UNDERWENT RIGHT KNEE REVISION SURGERY APPROXIMATELY 8 YEARS 8 MONTHS POST PRIMARY PROCEDURE. OPERATIVE REPORT OPERATIVE FINDINGS: GROSS PURULENCE AND INFECTION, LOOSE FEMORAL COMPONENT, LOOSE TIBIAL COMPONENT, WELL-FIXED PATELLAR COMPONENT, ADEQUATE SOFT TISSUE COVERAGE, AORI CLASS FEMUR 2B, AORI CLASS TIBIA 2B. POSTOPERATIVE DIAGNOSIS: PYOGNEIC ARTHRITIS OF RIGHT KNEE JOINT, DUE TO UNSPECIFIED ORGANISM. THE SURGEON NOTED ABUNDANT PURULENCE. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND COMPLETELY DEBONDED FROM THE BONE, WHERE ABUNDANT PURULENCE WAS NOTED IN THE FEMUR AROUND THE IMPLANT, WHICH WAS REMOVED. THE POLYETHYLENE WAS REMOVED AND THE TIBIAL COMPONENT WAS ALSO NOTED TO BE LOOSE WITH SEVERE BONE LOSS AND PURULENCE IN THE BONE. THE PATELLAR BONE HAD OSTEOLYSIS AS WELL OVER THE LATERAL FACET. SHE TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION. 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: Joint Laxity; Swelling/ Edema; Unspecified Infection

  MAUDE report 22815164 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 14 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, INFECTION, SWELLING, PAIN, DISCOMFORT, EMOTIONAL DISTRESS.. 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; Discomfort; Emotional Changes; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20147247 ↗
• InjuryJun 25, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 211 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISTINCT ANTERIOR KNEE PAIN PARTICULARLY WHEN GOING FROM SITTING TO STANDING AS WELL AS A SENSE OF CATCHING WHICH WAS PAINFUL. 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: Implant Pain; Joint Laxity; Pain; Synovitis

  MAUDE report 19607781 ↗
• InjuryDec 7, 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)2016. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18281699 ↗
• InjuryJun 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6) 2007 AND THEN APPROXIMATELY 15 YEARS, 7 MONTHS LATER HAD A SURGICAL REVISION ON (B)(6) 2022. THE PATIENT HAD SIMULTANEOUS KNEE REPLACEMENTS AND REVISION PROCEDURES. REVISION OPERATIVE REPORT OF (B)(6) 2022- THE FEMORAL AND TIBIAL COMPONENTS WERE VERY WELL FIXED. POLYETHYLENE LINER EXCHANGE DONE. LEFT SIDE UPSIZED TO 13MM CCK. THE PATELLA COMPONENT DEMONSTRATED WEAR AND WAS REVISED. THERE WAS A MODERATE DEGREE OF INFLAMED AND THICKENED SYNOVIUM CONSISTENT WITH CHRONIC SYNOVITIS. THE PATELLAR COMPONENT WAS NOT LOOSE BUT HAD POLYETHYLENE WEAR. THERE WAS WEAR ON THE ANTERIOR ASPECT OF THE BOX FOR THE TIBIAL INSERT. PROCEDURE: THERE WAS THICKENED INFLAMED SYNOVIUM CONSISTENT WITH POLYETHYLENE PARTICULATE DEBRIS-INDUCED PROCESS. A STERILE DRESSING WAS APPLIED TO THE KNEE AND THE PATIENT TAKEN TO RECOVERY IN STABLE CONDITION. HOSPITAL CARE: ADMITTED (B)(6) 2022/DISCHARGED (B)(6) 2022. 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; Synovitis

  MAUDE report 17200154 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  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 208-23-11-INSERTO TIBIAL CC 3,11MM, SERIAL NUMBER: (B)(6) ON (B)(6) 2017. THE INSERT WAS MANUFACTURED ON 8-OCT-2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 8-OCT-2015 AND WAS 2 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: Failure of Implant; Insufficient Information

  MAUDE report 16971311 ↗
• InjuryMay 19, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(6), 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 208-23-11-INSERTO TIBIAL CC 3,11MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 7/27/2009 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 7/27/2009 AND WAS 3.74 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: Failure of Implant; Insufficient Information

  MAUDE report 16962493 ↗
• InjuryMar 2, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL CASE, THAT A PATIENT, RIGHT KNEE IMPLANTED ON (B)(6) 2013, HAD DEVELOPED OSTEOLYSIS IN HIS RIGHT KNEE AS A RESULT OF THE FAILED POLYETHYLENE LINER, AND WAS SCHEDULED TO UNDERGO REVISION SURGERY ON (B)(6) 2023, TO REMOVE THE DEVICE. AS A RESULT OF DEFENDANTS¿ FAILURE TO PROPERLY PACKAGE THE OPTETRAK DEVICE PRIOR TO DISTRIBUTION, THE POLYETHYLENE LINER PREMATURELY DEGRADED AND PLAINTIFF REQUIRED REVISION SURGERY DUE TO SEVERE PAIN, SWELLING, AND INSTABILITY IN THE KNEE AND LEG. THESE INJURIES WERE CAUSED BY ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE INSERT. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE AS DESCRIBED HEREIN, THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES 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. AS A FURTHER DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE OPTETRAK DEVICE, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16465292 ↗

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-