Optetrak 204-25-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862048462), received between Feb 5, 2020 and Feb 5, 2025 — classified as 13 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.

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.

• InjuryFeb 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY ONE MONTH POST INITIAL OPERATION. PATIENT WAS REVISED DUE TO FEMORAL AND TIBIAL LOOSENING.

  Patient problems: Implant Pain; Pain; Scar Tissue

  MAUDE report 21312990 ↗
• InjurySep 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, RIGHT KNEE PAIN, INTERMITTENT LOWER BACK PAIN; INFECTION IN RIGHT KNEE, POSITIVE FOR GROUP B STREP. 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; Medical device site infection; Pain; Scar Tissue; Synovitis

  MAUDE report 20195673 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 143 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SUFFERING, TROUBLE WALKING/STANDING, NEED FOR ADDITIONAL SURGERY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20034345 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED IN (B)(6) OF 2009, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 15 YEARS POST THE INITIAL PROCEDURE. REVISION DATE UNKNOWN. THE SURGEON REMOVED THE OPTETRAK PS KNEE DUE TO POLY WEAR. THERE WERE SIGNS OF WEAR ON THE PATELLA AND LINER. THERE WERE ALSO SIGNS OF METALLOSIS. THERE WAS AN ABSENCE OF CEMENT ON A SIGNIFICANT PORTION OF THE BACKSIDE SURFACE OF THE FEMORAL COMPONENT. THE SURGEON REPLACED ALL COMPONENTS WITH A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. LEGAL INDICATED FOR THE REASON. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Metal Related Pathology

  MAUDE report 19620689 ↗
• InjuryApr 24, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED APPROXIMATELY 16 YEARS POST OP DUE TO PAIN AND SOME INSTABILITY. NO ISSUES WITH SURGERY A PSC WAS FOUND TO BE MORE STABLE AT SAME THICKNESS. EXPLANTS NOT AVAILABLE. SURGEON STATED THE ORIGINAL INSERT PERFORMED WELL.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 19177870 ↗
• InjuryMar 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THIS MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2011. THE PATIENT UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2018 SECONDARY TO POLYETHYLENE LINER WEAR. THE PATIENT UNDERWENT A SECOND REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2021 SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS OF THE FEMORAL COMPONENTS. RELATED TO 1038671-2023-00530.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Metal Related Pathology; Osteolysis; Unspecified Infection

  MAUDE report 16633099 ↗
• InjuryMar 28, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2011. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 SECONDARY TO COMPLETE POLYETHYLENE LINER WEAR AND DELAMINATION LINER WITH RESULTING SYNOVITIS, CYST FORMATION, OSTEOLYSIS OF THE FEMUR AND TIBIA, AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Cyst(s); Failure of Implant; Metal Related Pathology; Osteolysis; Pain; Synovitis; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 16633082 ↗
• InjuryOct 4, 2022Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS MALE PATIENT'S KNEE WAS REVISED 2 YEARS POST OP. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 15536848 ↗
• InjurySep 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD A LEFT KNEE IMPLANTED ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO UNKNOWN REASONS. NO OTHER INFORMATION PROVIDED.

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

  MAUDE report 15335254 ↗
• InjurySep 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT HAD A LEFT KNEE IMPLANT DATE OF (B)(6) 2008. THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 15335119 ↗
• InjuryDec 4, 2020Degraded; Degraded

  IT WAS REPORTED THAT A (B)(6) PATIENT AT (B)(6) (BMI: 40) EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO POLY WEAR. 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 10946486 ↗
• InjuryOct 14, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10681572 ↗
• InjuryFeb 5, 2020Naturally Worn; Naturally Worn

  AS REPORTED, THE INITIAL IMPLANT WAS ON (B)(6) 2011. THE PATIENT IS A LARGE (B)(6) Y/O MALE, BUT NOT OBESE. ON (B)(6) 2019, A REVISION WAS COMPLETED DUE TO "BAD POLY". THE SURGEON OPENED THE KNEE UP TO EXPOSE WELL FIXED IMPLANTS AND REMOVED THE EXISTING 9 MM THICK PS TIBIAL INSERT WHICH SHOWED POST WEAR AND MINOR ARTICULAR SURFACE WEAR. AFTER TRIALING VARIOUS INSERT THICKNESSES, THE SURGEON CHOSE TO PLACE A 10 MM THICK PS TIBIAL INSERT. THE PATIENT WAS STABLE UPON LEAVING THE OPERATING ROOM. IMAGES RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 9670732 ↗

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-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-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-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.