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Optetrak 204-24-11Recalls & reported problems

Exactech, Inc. · Class 2 · Implant

All models of Optetrak (336)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Exactech Optetrak knee implant is a cemented artificial joint that replaces the knee. Reports mostly describe the plastic bearing wearing down years after surgery, with pain, loosening and bone loss leading to repeat surgery to replace it. There are 25 reports naming its identifier, including 25 injuries and no deaths. It has 1 open recall from August 2021 about inserts packaged without an extra layer to keep oxygen out.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
25
Deaths reported
0
Injuries reported
25
Recalls naming it
1

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885862048394), received between Nov 11, 2019 and Nov 14, 2024 — classified as 25 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 5 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

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

Device problems

  • Naturally Worn19
  • Adverse Event Without Identified Device or Use Problem6
  • Insufficient Device Problem Information2
  • Loosening of Implant Not Related to Bone-Ingrowth2
  • Unstable2
  • Appropriate Device Problem Term/Code Not Available1
  • Detachment of Device or Device Component1

Patient problems

  • Failure of Implant14
  • Insufficient Information8
  • Implant Pain7
  • Pain6
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
  • Osteolysis4
  • Joint Laxity3
  • Joint effusion3

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 14, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 80 MONTHS AFTER A LEFT 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 20683822 ↗
  • InjuryNov 13, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 113 MONTHS AFTER A LEFT 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 20678221 ↗
  • InjuryOct 10, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 194 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20418791 ↗
  • InjurySep 4, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

    IT WAS REPORTED THAT THIS 76 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 7 YEARS 10 MONTHS POST OP. PATIENT HAD LOOSENING, PAIN, AND DECREASE IN JOINT FUNCTION. OPERATION CONCLUDED PS TO COMPETITORS CONSTRAIN TO TIBIA, PATELLA, AND FEMUR FINDINGS. THERE WAS GROSS LYSIS OF FEMUR, TIBIA AND PATELLA WITH UNCONTAINED POSTERIOR TIBIAL AND FEMORAL, WEAR OF POLY BEARING WITH SYMMETRICAL BILATERAL LOSS AND DISENGAGEMENT FROM BASEPLATE, NO EVIDENCE OF INFECTION BUT LARGE EFFUSION AND GRANULOMATOUS SYNOVITIS. THERE WAS LOOSENING OF PATELLA BUT FEMUR AND TIBIA STILL WELL FIXED - COMPONENTS NOT DAMAGED. METAL SEEN ON XRAY POSTEROMEDIAL TIBIAL BASEPLATE PLUG. PATIENT REVISED TO COMPETITORS DEVICES.

    Patient problems: Implant Pain; Joint effusion; Loss of Range of Motion; Osteolysis; Pain; Synovitis

    MAUDE report 20140377 ↗
  • InjuryJul 17, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 157 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PROGRESSIVE PAIN; LIMITED WALKING AND AVOIDED STAIRS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

    MAUDE report 19765008 ↗
  • 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 AND THEN APPROXIMATELY 7 YEARS, 10 MONTHS LATER THE PATIENT WAS REVISED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 19630174 ↗
  • InjuryJun 27, 2024Naturally Worn; Naturally Worn

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY APPROXIMATELY 6 YEARS 11 MONTHS AFTER THEIR PRIMARY PROCEDURE. THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: PATELLAR COMPONENT SHATTERING, AND INTENSE 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: Pain

    MAUDE report 19625927 ↗
  • InjuryJun 12, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

    MAUDE report 19524173 ↗
  • InjuryJun 10, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT APPROXIMATELY 49 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

    MAUDE report 19505647 ↗
  • InjuryJun 3, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 105 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INCREASING PAIN, SWELLING, AND INSTABILITY. UPON THE REVISION OF THE EXACTECH DEVICE, THE PLAINTIFF'S SURGEON OBSERVED SIGNS OF POLYETHYLENE WEAR, LOOSENING OF PROSTHETIC JOINT, A LARGE OSTEOLYTIC CYST BENEATH THE TIBIAL COMPONENTS, AND FEMORAL BONE LOSS. REVISION OP NOTES WERE NOT PROVIDED. 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; Swelling/ Edema

    MAUDE report 19453482 ↗
  • InjuryApr 23, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP REVISION PROCEDURE ON (B)(6) 2019 AND THEN WAS REVISED ON (B)(6) 2022. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, LOOSENING, OSTEOLYSIS, UNRECONSTRUCTABLE OSTEOLYSIS OF THE PATELLA, VARUS SUBSIDENCE OF THE TIBIAL COMPONENT. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

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

    MAUDE report 19166984 ↗
  • InjuryApr 5, 2024Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A MALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 8 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS BROUGHT BACK FOR RIGHT KNEE POLY WEAR. THE FEMUR WAS FOUND LOOSE WHEN CHECKING THE COMPONENTS. THE TIBIA WAS REMOVED AS WELL. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS REPORTED DURING THE PROCEDURE. X-RAY WAS PROVIDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THE PATIENT REQUESTED THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 19052036 ↗
  • InjuryMar 19, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2005, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2012 APPROXIMATELY 7 YEARS AND 1 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    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 18938381 ↗
  • InjuryOct 11, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 11 YEARS AND 6 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 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 (B)(6) 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

    Patient problems: Insufficient Information

    MAUDE report 17912460 ↗
  • InjuryMar 3, 2023Naturally Worn; Naturally Worn

    AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2014. THE PATIENT HAD A TIBIAL EXCHANGE ON (B)(6) 2018 DUE TO MALALIGNMENT AND THE DEFECTIVE NATURE OF THE DEVICE. DUE TO THE SURGEON PLACING THE LEG AND/OR COMPONENTS IN MALALIGNMENT, THIS CAUSED OR CONTRIBUTED TO THE PATIENT SUSTAINING DAMAGES TO HIS RIGHT KNEE AND SUFFER ONGOING PAIN, SWELLING, MALFUNCTION, AND NEED FOR ADDITIONAL SURGERIES. THE TIBIAL INSERTS' TENDENCY TOWARDS EARLY FAILURE AND THE CREATION OF EXCESSIVE DEBRIS AND FAILURE TO CONFORM TO SPECIFICATIONS WAS MADE WORSE BY MISALIGNMENT, AND THE MISALIGNMENT WAS MADE WORSE BY THE DEFECTIVE NATURE OF THE TIBIAL INSERTS, SO THAT THE PATIENT'S INSERT PREMATURELY FAILED AND HAD TO BE REMOVED AND REPLACED.

    Patient problems: Failure of Implant; Synovitis

    MAUDE report 16480377 ↗
  • InjuryOct 18, 2022Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT A PATIENT, INITIAL KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 5 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR POLY WEAR. NO FURTHER INFORMATION REPORTED.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 15628877 ↗
  • InjuryOct 11, 2022Naturally Worn; Naturally Worn

    AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2013. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO POLY WEAR. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Patient problems: Failure of Implant; Insufficient Information

    MAUDE report 15577203 ↗
  • InjuryMay 3, 2022Naturally Worn; Naturally Worn

    AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL LEFT TKA, THIS (B)(6) MALE PATIENT UNDERWENT REVISION OF THE TOTAL TKR OPTETRAK DUE TO POLY WEAR AND DEBRIS IN THE KNEE WERE INDICATED. THERE WAS NO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAYS REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE NOT ABLE TO BE OBTAINED BY SALES REP. DEVICE IMAGES RECEIVED. THE DEVICE WILL BE RETURN.

    Patient problems: Failure of Implant

    MAUDE report 14269728 ↗
  • InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED PER SALES REP, APPROXIMATELY FIVE YEARS POST INITIAL TKA, THIS PATIENT HAS A SCHEDULE KNEE REVISION ON (B)(6) 2022.

    Patient problems: Failure of Implant

    MAUDE report 13446564 ↗
  • InjuryJan 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    .AS REPORTED, APPROXIMATELY 20 YEARS POST INITIAL LEFT THA, THIS MALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: Failure of Implant

    MAUDE report 13389353 ↗
  • InjuryJan 5, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    AS REPORTED, PATIENT HAD A REVISION FOR AN UNKNOWN REASON. THIS IS NO PE LINER ISSUE DUE TO NON-CONFORMING EVOH BAGS. NO INCIDENT REPORTED TO EXACTECH (B)(4), NO MATERIOVIGILANCE KNOWN BY EXACTECH CORP OR EXACTECH (B)(4). NO ADDITIONAL INFORMATION AVAILABLE.

    Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Joint effusion; Synovitis

    MAUDE report 13172616 ↗
  • InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A (B)(6), PATIENT EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO A BONE FRACTURE. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Bone Fracture(s)

    MAUDE report 10946539 ↗
  • InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2009. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Unspecified Infection

    MAUDE report 10775748 ↗
  • InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2009, DUE TO UNREPORTED REASONS. INITIAL SURGERY DATE WAS NOT REPORTED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

    Patient problems: Failure of Implant

    MAUDE report 10681639 ↗
  • InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    APPROXIMATELY 9 YEARS POSTOPERATIVELY A TKA, A 75 Y/O MALE PATIENT WAS REVISED. THE SURGEON TOOK OUT THE 11MM POLY LINER AND REPLACED IT WITH A 15MM POLY. THIS GAVE THE PATIENT BETTER STABILIZATION. THE SURGEON THEN CLOSED THE KNEE IN STANDARD FASHION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE DISPOSED OF BY THE HOSPITAL.. UPON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED REVISION WAS LIKELY THE RESULT OF UNDERLYING PATIENT FACTORS, WHICH LED TO INSTABILITY OF THE JOINT.

    Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

    MAUDE report 9307770 ↗

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-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-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.

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Sources and updates

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