Optetrak 204-22-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862048240), received between Oct 12, 2020 and Jul 7, 2025 — classified as 13 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.

7 other recalls cover devices cleared under the same FDA submission (K933610); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 8 YEARS 6 MONTHS POST INITIAL OPERATION. PATIENT WAS EXPERIENCING PREMATURE WEAR OF THE POLYETHYLENE WITH MECHANICAL LOOSENING OF THE IMPLANT SECONDARY TO MASSIVE OSTEOLYSIS. PATIENT WAS REVISED TO A COMPETITOR'S DEVICE.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 22411232 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK CLASSIC DEVICE ON THE LEFT KNEE AND THEN APPROXIMATELY 13 YEARS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19615178 ↗
• InjuryMay 23, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAS FILED A LONG-FORM COMPLAINT IN THE CIRCUIT COURT OF THE EIGHT JUDICIAL CIRCUIT IN AND FOR (B)(6). THE PATIENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE NATURE OF THE IMPLANT WHICH NECESSITATED PREMATURE REMOVAL, THE PATIENT SUFFERED SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. PER THE INFORMATION AVAILABLE IN THE LEGAL DOCUMENTATION PROVIDED, THE PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANATION OF THE LEFT KNEE AT ISSUE. THE PATIENT HAS HAD A RIGHT KNEE REVISION (B)(6) THAT IS ALSO COVERED IN THIS LEGAL LONGFORM.

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

  MAUDE report 19383597 ↗
• InjuryApr 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 64 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 9 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT¿S OPTETRAK CLASSIC PS POLY ON AN OPTETRAK CC FEMORAL COMPONENT WERE BEING REVISED FOR PAIN AND WEAR. DURING THE SURGERY, ONLY A TRULIANT ACTIVIT-E PS & PSC POLY WERE AVAILABLE, SO THE SURGEON IMPLANTED A TRULIANT PSC ACTIVIT-E POLY BUT KEPT THE OPTETRAK CC FEMUR IN PLACE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19121944 ↗
• InjurySep 8, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2005. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY 5 YEARS 10 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT FINDINGS: EXTENSIVE SYNOVITIS WITH THICK RIND WITH BLOOD + PURULENT EFFUSION CONSISTENT WITH CHRONIC INFECTION. AORI II A BONE LOSS LATERAL TIBIA AND LATERAL FEMUR. EXTENSIVE OSTEOLYSIS OF THE PATELLA. IMPLANTS NOT GROSSLY LOOSE. SEVERE POLYETHYLENE WEAR WITH SEVERE DELAMINATION AND YELLOW DISCOLORATION OF THE INSERT. WEAR OF THE PATELLAR BUTTON. GROSSLY UNSTABLE TO VARUS VALGUS STRESS IN EXTENSION AND FLEXION. 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; Joint Laxity; Joint effusion; Medical device site infection; Osteolysis; Pain; Synovitis

  MAUDE report 17710592 ↗
• InjuryJul 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2006. APPROXIMATELY 17 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: FAILED RIGHT KNEE ARTHROPLASTY. FINDINGS ON EXAM AND IMAGING WERE CONSISTENT WITH THE KNOWN ISSUE OF ACCELERATED POLYETHYLENE WEAR ASEPTIC LOOSENING. IMAGINE WAS CONSISTENT WITH FAILED RIGHT KNEE ARTHROPLASTY. THE POLYETHYLENE COMPONENT DEMONSTRATED ACCELERATED POLYETHYLENE WEAR. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 17316875 ↗
• InjuryMar 21, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED BY LEGAL DOCUMENT, THE 80 Y/O FEMALE PATIENT UNDERWENT TOTAL ARTHROPLASTY OF THE LEFT KNEE IN (B)(6) 2013 FOR THE TREATMENT OF OSTEOARTHRITIS, THE PROSTHESIS MANUFACTURED BY EXACTECH, MODEL OPTETRAK, WAS PLACED, THE PATIENT EVOLVED WITH PREMATURE WEAR OF THE POLYETHYLENE, WITH THE INTENSE OSTEOLYSIS AROUND THE FEMORAL AND TIBIAL COMPONENTS, CULMINATING IN THE LOOSENING OF THE PROSTHESIS AND NOW REQUIRING THE REPLACEMENT OF COMPONENTS FOR REVISION COMPONENTS. IN MARCH 2022, THE COMPANY ITSELF RELEASED A WORLDWIDE RECALL FOR THIS TYPE OF IMPLANT, ALLEGING A DEFECT IN THE PACKAGING, WHICH ALLOWED THE POLYETHYLENE TO COME INTO CONTACT WITH OXYGEN AND UNDERGO OXIDATION, WHICH WOULD LEAD TO ITS PREMATURE WEAR, WITH ALL THE CONSEQUENCES. ON (B)(6) 2023, PATIENT WAS SUBMITTED TO REVISION OF THE TOTAL PROSTHESIS OF THE LEFT KNEE, WITH THE REMOVAL OF ALL COMPONENTS, INTENSE WEAR OF THE POLYETHYLENE VERIFIED, WITH DELAMINATION PATTERN, WITH THE BREAKAGE OF THE POST. SURGEON OBSERVED INTENSE OSTEOLYSIS, CAVITARY IN THE PROXIMAL TIBIA, PATELLA AND DISTAL FEMUR, BEING THE LATERAL EPICONDYLE ABSENT. PATIENT WAS REVISED TO COMPETITOR'S DEVICE. AS AN INTERCURRENCE, SURGEON REPORTED THE

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 16582289 ↗
• InjuryMar 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL REVISION OF HER FAILED RIGHT OPTETRAK DEVICE ON (B)(6) 2015. UPON EXPLANTATION OF THE OPTETRAK DEVICE, PLAINTIFF¿S SURGEON OBSERVED THAT THE TIBIAL COMPONENT WAS LOOSE AND SHOWED GROSS MOTION. IN THE YEARS FOLLOWING THE REVISION SURGERY, PLAINTIFF ONCE AGAIN EXPERIENCED PAIN, SWELLING, INSTABILITY, AND BONE LOSS IN HER RIGHT KNEE CAUSED BY EARLY AND ACCELERATED POLYETHYLENE WEAR AND/OR COMPONENT LOOSENING. THE PAIN AND INSTABILITY IN PLAINTIFF'S RIGHT KNEE CONTINUED TO BECOME MORE SEVERE, AND IT BECAME NECESSARY TO UNDERGO A SECOND RIGHT KNEE REVISION SURGERY, WHICH WAS PERFORMED ON (B)(6) 2019, APPROXIMATELY 3 YEARS 2 MONTHS POST REVISION PROCEDURE. PLAINTIFF¿S CLINICAL, LABORATORY, AND RADIOLOGICAL WORKUP ON HER RIGHT KNEE WERE NEGATIVE FOR INFECTION, BUT POSITIVE FOR LOOSENING SECONDARY TO OSTEOLYSIS SECONDARY TO POLYETHYLENE WEAR. DURING THE SECOND REVISION SURGERY, IT WAS NOTED THAT BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AND REMOVED WITH MINIMAL EFFORT. UPON EXPLANTATION OF THE OPTETRAK DEVICE, THE SURGEON OBSERVED ¿SIGNIFICANT WEAR IN THE MEDIAL ASPECT AND AROUND THE POSTERIOR POST¿ OF THE TI

  Patient problems: Implant Pain

  MAUDE report 16460776 ↗
• InjuryFeb 17, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS FEMALE PATIENT IS BEING REVISED TO A HINGED KNEE. IN RECENT MONTHS, PATIENT HAS REPORTED INCREASE IN KNEE PAIN. SURGEON THOUGHT IT MIGHT BE A CHRONIC INFECTION ISSUE BUT BELIEVES THIS IS A POLY WEAR ISSUE AS IMAGINE SHOWS ASYMMETRY IN THE POLY.

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

  MAUDE report 16395802 ↗
• InjuryOct 4, 2022Loss of or Failure to Bond; Unstable; Loss of or Failure to Bond; Unstable

  IT WAS REPORTED THAT A 79 YO MALE, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2002, HAD LOOSENING OF JOINT SPACE OVER TIME, AND WAS REVISED ON (B)(6) 2022, APPROXIMATELY 20 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. PT HAD A 13MM POLY IMPLANTED. ONLY SIZES 13MM, 15MM, AND 30MM WERE AVAILABLE FROM EXACTECH. 15MM WAS TOO LOOSE AND THE 30MM WAS JUST TOO BIG. SURGEON HAD TO PULL EVERYTHING AND REVISED USING COMPETITORS DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 15540527 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 11 YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO DEBRIS SYNOVITITIS. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Synovitis

  MAUDE report 13389206 ↗
• InjuryDec 1, 2021Fracture; Fracture

  AS REPORTED, APPROXIMATELY 9 YRS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENT PRESENTED WITH A WORN-OUT RIGHT KNEE PATELLA AND PATELLA TRACKING ISSUE. THE PATELLA WAS REPLACED AS WELL AS THE PE INSERT. THE INSITU PATELLA WAS WORN DOWN TO THE BONE ON BOTH SIDES AND THE PE PS POST HAD BEEN SNAPPED OFF THE MAIN BODY OF THE PE - EXCHANGE WAS PERFORMED AT THE SAME TIME OF SURGERY. ALL PIECES OF THE PATELLA WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE TO BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12908614 ↗
• InjuryOct 12, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2002. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10661604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. One submission often covers many models, so check the product and lot details in each record.

• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• 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-
• Z-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.