Optetrak 204-24-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862048417), received between Apr 28, 2022 and Aug 21, 2024 — 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.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 131 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 20017841 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 20 MONTHS AFTER A RIGHT 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; Joint Laxity; Pain

  MAUDE report 19905842 ↗
• InjuryJul 10, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 178 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE WITH DR. (B)(6), MD AT (B)(6) IN (B)(6), TO ADDRESS PROGRESSIVE DEBILITATION AND PAIN WITH SWELLING AND INSTABILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. HE HAD NO CLINICAL SIGNS OF INFECTION. X-RAYS SHOW COMPONENTS TO BE WELL-FIXED AND IN GOOD POSITION WITHOUT ANY SIGNS OF EXCESSIVE OSTEOLYSIS. PREOPERATIVE AND POSTOPERATIVE NOTES INDICATED FAILED LEFT TOTAL KNEE REPLACEMENT. INTRAOPERATIVE FINDINGS REVEALED DIFFUSE HYPERTROPHIC AND INFLAMED SYNOVIUM. THERE WAS A LARGE AMOUNT OF NORMAL-APPEARING JOINT FLUID WITHOUT ANY SIGNS OF INFECTION. ALL COMPONENTS WERE WELL-FIXED AND IN GOOD POSITION. THE PATELLAR POLYETHYLENE WAS SIGNIFICANTLY WORN WITH PITTING AND DELAMINATION. THE POLYETHYLENE LINER SHOWED SEVERE MEDIAL WEAR WITH PITTING AND DELAMINATION. THE POLYETHYLENE SPINE HAD A BROKEN AND WAS LOOSE WITHIN THE JOINT. THE FEMUR AND PATELLA WERE REVISED WITH INSERTION OF A CONSTRAINED CONDYLAR INSERT. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE WERE NO COMPLICATIONS. NO ADDITIONAL INFOR

  Patient problems: Insufficient Information; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19715161 ↗
• InjuryJun 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 132 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, AND INSTABILITY. UPON THE REVISION OF THE OPTETRAK DEVICE, THE PLAINTIFF'S SURGEON OBSERVED SIGNS OF BONE LOSS ON THE TIBIAL SIDE OF THE KNEE, SIGNIFICANT SIGNS OF OSTEOLYSIS, A GROSSLY LOOSE AND UNSTABLE FEMORAL COMPONENT, AND SIGNIFICANT WEAR IN THE PATELLAR BUTTON. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19475961 ↗
• InjuryDec 19, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A SECOND RIGHT REVISION ON (B)(6) 2013. APPROXIMATELY 3 MONTHS AFTER THE REVISION THE PATIENT HAD A THIRD RIGHT KNEE REVISION ON (B)(6) 2013. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(6). 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 O

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Insufficient Information; Medical device site infection; Swelling/ Edema

  MAUDE report 18354269 ↗
• InjuryDec 18, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2013. APPROXIMATELY 3 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2013. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY 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 W

  Patient problems: Implant Pain; Insufficient Information; Medical device site infection; Nausea; Necrosis; Swelling/ Edema; Vomiting

  MAUDE report 18348098 ↗
• InjuryOct 5, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT HAD A REVISION APPROXIMATELY 8.5 YEARS POST OP DUE TO POLY WEAR.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15546801 ↗
• InjuryApr 28, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, PATIENT ORIGINAL SURGERY WAS PERFORMED IN 2014. PATIENT MOVED TO A DIFFERENT CITY AFTER THE PRIMARY SURGERY. PATIENT HAS HAD TWO (2) REVISIONS, AND PATIENT HAD PAIN AND ISSUES FOLLOWING THE PRIMARY SURGERY. WHEN PATIENT HAD FIRST REVISION IN 2017, THE SURGEON CORRECTED A ¿PATELLAR ISSUE¿ (THE PATELLAR BUTTON WAS LOOSE HE THOUGHT), AND ¿TIGHTENED THE KNEE¿. HOWEVER, ONLY THE INSERT WAS EXCHANGED. THE PATIENT CONTINUING PAIN AND MOBILITY ISSUES, THEN IN (B)(6) 2021 HAD A SECOND REVISION. PATIENT BELIEVES ALL THE COMPONENTS WERE REMOVED IN 2021, AND SURGEON SAID HE HAD SIGNIFICANT LYSIS. PATIENT HAS HAD TO WORK FROM HOME SINCE THE SURGERY, HAS LEG LENGTH ISSUES, CONTINUING PAIN, ETC. PATIENT IS MALE, (B)(6) AND HAS VERY LIMITED MOBILITY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 14244039 ↗

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.