Optetrak 204-04-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862047663), received between Oct 14, 2020 and Mar 24, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 reports).

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 16, 2026.

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.

• InjuryMar 24, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, OSTEOLYSIS AND PROSTHESIS WEAR. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 13 YEARS AFTER INITIAL IMPLANTATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Cyst(s); Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 24680658 ↗
• InjuryJan 29, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 116 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, RIGHT KNEE PAIN AND SWELLING, PROMINENT OSTEOLYSIS INVOLVING THE RIGHT TIBIA, FEMUR, AND PATELLA, CORTICAL DEHISCENCE, PATHOLOGIC FRACTURE OF THE MEDIAL FEMORAL CONDYLE, SYNOVIAL PROLIFERATION THROUGHOUT THE RIGHT KNEE JOINT, POST-REVISION SURGICAL PAIN, AND PERMANENT RIGHT KNEE IMPAIRMENT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21266737 ↗
• InjuryJan 7, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2014. THE PATIENT WAS REVISED APPROXIMATELY 8 YEARS AND 2 MONTHS LATER ON (B)(6) 2022. JOINT FLUID WAS OBTAINED AND SENT FOR CULTURE AND SENSITIVITY X3. EXTENSIVE SYNOVITIS FROM THE POLYETHYLENE WAS NOTED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND WAS REMOVED WITH OSTEOTOMES. THE TIBIAL COMPONENT AND PATELLA WERE ALSO GROSSLY LOOSE AND WERE REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Synovitis

  MAUDE report 21095981 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND SCAR TISSUE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. PATIENT UNDERWENT REVISION RIGHT KNEE (B)(6) 2014. PRE/POST OP: PAINFUL RIGHT TKA PROCEDURE: REVISION RIGHT TKA ¿ TIBIAL COMPONENT ONLY FINDINGS: NO INFECTION ARTHROFIBROSIS TISSUE ABOUT THE PATELLA. INDICATIONS FOR SURGERY: PATIENT IS A 49-YEAR-OLD FEMALE WHO HAS HAD BOTH KNEES REPLACED. SHE DID WELL WITH THE LEFT KNEE REPLACEMENT, HOWEVER, SHE HAS HAD SOME CONTINUED PAIN WITH THE RIGHT KNEE REPLACEMENT. SHE UNDERWENT AN EXTENSIVE WORKUP. INFECTION WORK-UP WAS NEGATIVE. THE TIBIAL COMPONENT BASED ON A DT SCAN WAS READ AS VERY MILDLY INTERNALLY ROTATED AT 21 DEGREES. GIVIN THE AMOUNT OF PAIN SHE WAS HAVING AND THE FACT THAT THE PATELLA WAS SOMEWHAT SUBLUXED LATERALLY. IT WAS DECIDED TO PROCEED WITH A REVISION. I WAS CONFIDENT THE FEMORAL COMPONENT WAS WELL FIXED AND POSITIONED HOWEVER, WE WERE PREPARED TO REVISE THAT, IF NECESSARY, THE PLAN WAS FOR A TIBIAL REVISION AND TO ADDRESS THE PATELLA. OPERATIVE NOTES: THE TIBIAL COMPONENT WAS EASILY REMOVED WITH MINIMAL BONE LOSS. SH

  Patient problems: Pain; Scar Tissue

  MAUDE report 21093027 ↗
• InjuryDec 9, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SECONDARY TO SIGNIFICANT POLYETHYLENE LINER WEAR WITH RESULTING METALLOSIS, OSTEOLYSIS, AND SYNOVITIS, DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. THERE IS NO DEVICE RETURN. . INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR AND LOOSENING OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; High metal ion levels; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20883303 ↗
• InjuryOct 24, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT ON (B)(6) 2019, THE FEMALE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR, APPROXIMATELY 6 YEARS 2 MONTHS AFTER THE FIRST REVISION PROCEDURE. IT IS STATED THAT DESPITE UNDERGOING THE REVISION SURGERIES, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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 HAS BILATERAL KNEE REPLACEMENTS.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Joint Laxity; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20527101 ↗
• InjurySep 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 173 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN; EFFUSION, SEVERE SYNOVITIS AND OSTEOLYSIS; FEMORAL AND TIBIAL LOOSENING; DISCOLORATION AND DELAMINATION OR BREAKAGE ON THE TIBIAL INSERT, POSSIBLE DEFECT OF THE PATELLA POLYETHYLENE. 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: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20212787 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA PATIENT ID: (B)(6) + LEFT KNEE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 181 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, POLYETHYLENE WEAR OF TIBIAL INSERT AND PATELLA, FEMORAL AND TIBIAL LOOSENING; TIBIAL BONE FRACTURE. 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: Bone Fracture(s); Failure of Implant; Implant Pain; Pain; Scar Tissue

  MAUDE report 20054564 ↗
• InjuryJul 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH KNEE REPLACEMENT STUDY, THAT A 74 YO FEMALE PATIENT WHO WAS INITIALLY IMPLANTED ON (B)(6) 2012 ON THE RIGHT SIDE FOR THE PRIMARY DIAGNOSIS OF OSTEOARTHRITIS, HAD TIBIAL LOOSENING AFTER A FALL AND UNDERWENT A REVISION APPROXIMATELY 5 YEARS 3 MONTHS POST THE INITIAL IMPLANT FOR MECHANICAL LOOSENING OF A TIBIAL COMPONENT. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES OR PROCEDURE. THE STUDY INDICATES THE EVENT WAS RESOLVED (B)(6) 2017.

  Patient problems: Insufficient Information

  MAUDE report 15105184 ↗
• InjuryNov 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2006. THIS PATIENT HAD BILATERAL KNEE SURGERY. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10775734 ↗
• InjuryNov 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2006. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10775710 ↗
• InjuryOct 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2011, DUE TO ASEPTIC LOOSENING. 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 10702463 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2009, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681630 ↗

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-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-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-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.