Optetrak 204-24-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862048400), received between Oct 19, 2020 and Mar 2, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Naturally Worn; Lack of Effect

  IT WAS REPORTED A 69 YO MALE PATIENT, WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 16 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF STIFFNESS FROM SWELLING, PAIN, AND DISSATISFACTION WITH THEIR LEFT TOTAL KNEE. DECREASED MOTION WAS PRESENT. THE PATIENT WAS SCHEDULED FOR A REVISION OF LEFT TKA POSSIBLE POLYETHYLENE SWAP VS. FEMORAL COMPONENT REVISION. THE PATIENT HAD REVISION SURGERY AND UNDERWENT A TIBIAL POLY IMPLANT SWAP AND PATELLA IMPLANT SWAP. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24492121 ↗
• InjuryJan 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 189 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, AMBULATION DIFFICULTIES, DISCOMFORT, PAIN, OSTEOLYSIS, AND BALANCE PROBLEMS. INITIAL 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Osteolysis; Pain

  MAUDE report 21081918 ↗
• InjuryDec 30, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND PAIN. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, SIGNIFICANT OSTEOLYSIS AROUND THE FEMORAL COMPONENT AND DAMAGE TO THE TIBIAL POLYETHYLENE AS A CONSEQUENCE OF CEMENT FRAGMENTATION. INTRAOPERATIVELY THE SURGEON OBSERVED THE TIBIAL INSERT WAS WELL FIXED BUT WAS ELECTED BY SURGEON TO REPLACE THE INSERT. IT WAS NOTED THERE WAS NO SIGNIFICANT OSTEOLYTIC CHANGES AFFECTING THE TIBIAL INSERT COMPONENT. THE SURGEON OBSERVED SYNOVITIS THROUGHOUT THE KNEE AND THE FEMORAL COMPONENT LOOSE WITH OSTEOLYTIC CYSTS IN THE FEMORAL CONDYLES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); Discomfort; Failure of Implant; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21035248 ↗
• InjurySep 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, STIFFNESS AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20294429 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 78 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, LOSS OF MOBILITY, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19906233 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK CLASSIC DEVICE ON THE RIGHT KNEE, 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: Insufficient Information

  MAUDE report 19630292 ↗
• InjuryJun 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) PATIENT ID: (B)(6) . (B)(4). IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 128 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. 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; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19454338 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 180 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19268084 ↗
• InjurySep 26, 2023Crack; Detachment of Device or Device Component; Naturally Worn; Crack; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, APPROXIMATELY TEN YEARS POST INITIAL RIGHT TKA, THE 69 Y/O MALE PATIENT HAD A REVISION DUE TO MASSIVE OSTEOLYSIS ISSUE DUE TO POLY WEAR. ALL IMPLANTS WERE REMOVED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED AT THE HOSPITAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint effusion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 17822513 ↗
• InjuryMar 29, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION- REVISION SURGERY OF (B)(6) 2016- FAILED RIGHT TOTAL KNEE SECONDARY TO POLYETHYLENE FAILURE WITH METALLOSIS. SUBTOTAL SYNOVECTOMY TAKING OUT ALL METALLOSIS IN THIS SYNOVIAL TISSUE. THE FEMUR WAS ALSO GROSSLY LOOSE AND DISASSOCIATED WITH THE ENTIRE STEM IN ONE PIECE. THE LATERAL CONDYLE WAS ESSENTIALLY NONUNION WITH SIGNIFICANT BONE LOSS ALL THE WAY UP PAST THE LATERAL COLLATERAL LIGAMENT STRUCTURES. THE MEDIAL SIDE ULCER SHOWED A SIGNIFICANT AMOUNT OF OSTEOLYSIS AROUND THE CONDYLE SO A DECISION WAS MADE TO DO A DISTAL FEMORAL REPLACEMENT. THE PATIENT HAD NO COMPLICATIONS DURING THE CASE. HE WAS TAKEN TO THE PACU WITHOUT INCIDENT. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 16635949 ↗
• InjuryNov 15, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY THE LEGAL DEPARTMENT, A PATIENTS HAD OSTEOARTHRITIS OF L KNEE WITH SEVERE MEDIAL COMPARTMENT DEGENERATIVE CHANGES; STATUS POST SEGMENTAL FEMUR FRACTURE WITH SIGNIFICANT MALALIGNMENT CHANGES REQUIRED LEFT KNEE REPLACEMENT. APPROXIMATELY 10 YEARS POST OP THE INITIAL LEFT KNEE, THIS 53 Y/O MALE PATIENT WAS REVISED DUE TO THE REPLACEMENT SEPARATING. PATIENT WAS UNABLE TO TO REVISED RIGHT AWAY DUE TO MEDICAL ISSUES. IT IS STATED THAT AS A RESULT, THE PATIENT HAD TO DEAL WITH A LOT OF PAIN AND WAS LIMITED IN THEIR ABILITY TO WALK OR STAND. IN THE LAST FEW YEARS BEFORE THE REVISED SURGERY, HE HAD TO USE A CANE AND, AT TIMES, REQUIRED ADDITIONAL ASSISTANCE IN PERSONAL CARE. NO ADDITIONAL INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 15796354 ↗
• InjurySep 13, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, THE PATIENT HAD A INITIAL LEFT TKA ON (B)(6) 2010. IN APPROXIMATELY 2016, THE PATIENT HAD A REVISION DUE TO POLYMER WEAR AND LAXITY. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain

  MAUDE report 15414718 ↗
• InjuryMay 11, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIFTEEN YEARS POST INITIAL LEFT TKA, THE (B)(6) MALE PATIENT HAD A FULL REVISION GOING TO A CONSTRAINED KNEE. PATIENT'S REVISION WAS DUE TO INSTABILITY OF FEMORAL COMPONENT. THERE WAS POLY WEAR AND METALLOSIS DUE TO THE 8MM TIBIAL SPACER AND OSTEOLYSIS WAS ALSO PRESENT. PATIENT WAS REVISED TO A SIZE 4 LEFT CONSTRAINED FEMUR WITH SPLINED STEMS IN THE FEMUR AND TIBIA AS WELL AS METAPHYSEAL CONES AND A 25 MM CONSTRAINED LINER. THERE WAS NO DEVICE BREAKAGE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND PHOTOS RECEIVED. THE DEVICES WILL BE RETURNED. AS OF NOTE: "PATIENT WAS REVISED IN 2014 WITH LOOSENING OF THE TIBIA AND THE SIZE 4/13MM POSTERS STABILIZED TIBIAL INSERT REFERENCE NUMBER 204¿24¿13 WITH SERIAL NUMBER (B)(4). IS A NON-CONFORMED INSERT THAT IT IS ON THE LIST OF POLYS".

  Patient problems: Failure of Implant

  MAUDE report 14357051 ↗
• InjuryOct 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2010, DUE TO INSTABILITY. 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 10702460 ↗

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.