Optetrak 204-23-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885862048318), received between Oct 7, 2020 and Oct 16, 2025 — classified as 26 injuries.

The most frequently reported specific device problem is “Naturally Worn” (21 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Naturally Worn; Naturally Worn

  AS REPORTED, A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR WEAR OF THE PATELLA AND POLY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23308882 ↗
• InjuryAug 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST INITIAL OPERATION. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE, THERE WAS MILD OSTEOLYSIS PRESENT. THE PATELLA EXHIBITED MILD WEAR ALONG LATERAL TRACKING PATH AND HAD DISASSOCIATED FROM PEGS. THE TIBIAL INSERT HAD MILD WARE MEDIALLY AND LATERALLY BUT THE FEMORAL AND TIBIAL COMPONENT WERE WELL FIXED. OVERALL, THE LINER AND PATELLA WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 22795234 ↗
• InjuryJul 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD AN INITIAL RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. SEVERE OSTEOLYSIS PRESENT. SEVERE DAMAGE TO THE TIBIAL INSERT. UPON FURTHER INSPECTION, THE FEMORAL COMPONENT HAD LOOSENED. ALL COMPONENTS WERE REMOVED AND REVISED TO ANOTHER SYSTEM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL RETAINED THEM FOR ANALYSIS. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 22661285 ↗
• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 15 YEARS AND 10 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. PATELLA EXHIBITED SEVERE WEAR ALONG TRACKING PATH. THE TIBIAL INSERT HAD MILD WEAR MEDIALLY AND POSTERIORLY. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE PATELLA AND LINER WERE EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 21560235 ↗
• InjuryJan 27, 2025Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 70 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, OSTEOLYSIS, PAIN AND SYNOVITIS. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Osteolysis; Pain; Synovitis

  MAUDE report 21240409 ↗
• InjurySep 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, INSTABILITY, EFFUSION, PAIN AND INFLAMMATION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Implant Pain; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20192286 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 74 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND POLYETHYLENE DISEASE . 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: Insufficient Information; Scar Tissue

  MAUDE report 19911538 ↗
• InjuryJul 22, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF LEFT TOTAL KNEE REPLACEMENT SECONDARY TO POLYETHYLENE LINER RESULTING IN BONE LOSS AND A LOOSE TIBIAL COMPONENT AS WELL LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. A LWEAR AND BREAKING OF THE POLYETHYLENE LINER, OSTEOLYSIS, . POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 19792868 ↗
• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 11 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: Insufficient Information

  MAUDE report 19772761 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  LEGAL CASE (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 170 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, DISCOMFORT, DIFFICULTY WALKING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 19660548 ↗
• InjuryJun 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, BONE LOSS, LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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; Joint Laxity

  MAUDE report 19524145 ↗
• InjuryMay 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2014, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 9 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19388856 ↗
• InjuryMay 1, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 168 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, SWELLING, POLYETHYLENE WEAR, 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; Implant Pain; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19226151 ↗
• InjuryDec 29, 2023Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS MALE PATIENT HAD A PARTIAL REVISION ON DECEMBER 6TH. THE PATIENT WAS SUFFERING FROM KNEE HYDARTHROSIS, INTERNAL & EXTERNAL LAXITY, PAINFUL KNEE, SWELLINGS & INSTABILITY. SYNOVECTOMY WAS PERFORMED, PE CHANGED & CONTROL OF OTHER IMPLANTS. SURGEON IS EXPECTING A FULL & EXHAUSTIVE REPORT ON FINDINGS REGARDING THIS EXPLANT.

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

  MAUDE report 18418671 ↗
• InjuryJul 20, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2006. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 16 YEARS 6 MONTHS AFTER THEIR INITIAL IMPLANTATION. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: POLYETHYLENE PARTICULATE DEBRIS INDUCED SYNOVITIS WITH POLYETHYLENE WEAR LEFT TOTAL KNEE REPLACEMENT IN THE EXACTECH RECALL GROUP. PREOPERATIVE MRI DEMONSTRATED MINIMAL EVIDENCE OF OSTEOLYSIS. AT THE TIME OF SURGERY THERE WAS FOUND TO BE MODERATE VARUS AND VALGUS LAXITY. SURGICAL FINDINGS INCLUDED SYNOVITIS AND CHRONICALLY INFLAMED SYNOVIUM CONSISTENT WITH REACTION TO THE POLYETHYLENE PARTICULATE DEBRIS. ALL COMPONENTS INCLUDING FEMORAL, TIBIAL, AND PATELLA WERE WELL FIXED. THERE WAS EARLY WEAR ON THE POLYETHYLENE INSERT. THE PATIENT BROUGHT TO RECOVERY IN STABLE CONDITION. 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; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17363985 ↗
• InjuryJun 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 77 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. 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 (B)(6) 2022 DIAGNOSIS: LEFT KNEE POLYETHYLENE WEAR AND OSTEOLYSIS WITH LOOSE COMPONENTS DUE TO POLY RECALL. FINDING: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS FOUND TO BE MODERATE WEAR OF THE POLYETHYLENE INSERT WITH EVIDENCE OF SYNOVIAL POLYETHYLENE DEBRIS ENCAPSULATION. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT AND A PARTIALLY-FIXED TIBIAL COMPONENT AND A LOOSE PATELLAR BUTTON. NO COMPLICATIONS. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque; Osteolysis

  MAUDE report 17088088 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA DOCUMENTATION FROM THE LEGAL DEPARTMENT THAT A PATIENT HAD A TOTAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2010 AND THEN APPROXIMATELY 4 YEARS, 11 MONTHS, ON (B)(6) 2015 THE PATIENT HAD A REVISION, THE PATIENT COMPLAINED OF PAIN. 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 problems: Implant Pain

  MAUDE report 16987258 ↗
• InjuryMay 11, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 74 Y/O FEMALE PATIENT RIGHT KNEE WAS REVISED. REASON FOR THE REVISION IS UNKNOWN. SURGEON REMOVED CLASSIC OPTETRAK PS FEMUR AND FIN TRAY AND SIZE 3PS 11 INSERT, REVISED TO LOGIC CC. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16910145 ↗
• InjuryMar 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, A PATIENT HAD AN INITIAL TKA ON (B)(6) 2011. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO UNKNOWN REASONS. NO OTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 16643847 ↗
• InjuryMar 21, 2023Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT THE PATIENT, UNDERWENT INITIAL TOTAL KNEE REPLACEMENT SURGERY ON HER LEFT KNEE ON (B)(6) 2010. IN THE YEARS FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED PAIN, SWELLING, INSTABILITY, AND BONE LOSS IN HER LEFT KNEE CAUSED BY EARLY AND ACCELERATED POLYETHYLENE WEAR AND/OR COMPONENT LOOSENING. ON (B)(6) 2021, APPROXIMATELY 10 YEARS 3 MONTHS POST INITIAL PROCEDURE, PATIENT UNDERWENT AN EXTENSIVE REVISION SURGERY ON HER LEFT KNEE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Implant Pain; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16584084 ↗
• InjuryFeb 15, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2008 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF HAS NOT YET UNDERGONE A REVISION SURGERY OF HER RIGHT KNEE AS OF TODAY. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH OF HER KNEES WHICH LIMITS HER DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 16378505 ↗
• InjuryFeb 15, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2008 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 14 YEARS 2 MONTHS POST INITIAL PROCEDURE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH OF HER KNEES WHICH LIMITS HER DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16378276 ↗
• InjuryNov 29, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA IN (B)(6) 2018. THE PATIENT STARTED TO FEEL PAIN AND DISCOMFORT IN THE KNEE AROUND (B)(6) 2021 AND CONSULTED WITH HIS SURGEON IN (B)(6) 2021 WITH SWELLING AND LIMPING WHEN WALKING. THE PATIENT UNDERWENT COMPLEMENTARY EXAMS THAT INDICATED LOOSENING OF THE PROSTHESIS WITH POLYETHYLENE WEAR AND BONE LYSIS IN THE TIBIAL PLATEAU. THE PATIENT WAS REVISED WITH A SPACER IN LATE (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15883327 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY FOUR YEARS POST TKA, PATIENT HAD A REVISION FOR AN UNKNOWN REASON. IT IS UNKNOWN IF THIS IS A SECOND TIME REVISION FOR THE SAME SIDE. IT IS ALSO UNKNOWN WHY CC INSERT OUT OF SCOPE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 13172927 ↗
• InjuryOct 14, 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 10681569 ↗

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-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-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-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-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.