Optetrak 204-22-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885862048233), received between Oct 12, 2020 and Feb 24, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Naturally Worn” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Naturally Worn

  REPORT #1 OF 2 FOR THIS EVENT. IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. THE PATIENT'S LEFT KNEE IS UNREVISED AT TIME OF REPORTING. SUBSEQUENTLY, APPROXIMATELY ELEVEN (11) YEARS, LATER THE PATIENT HAS FILED LEGAL DOCUMENTATION AND ALLEGES EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Metal Related Pathology; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 24427998 ↗
• InjurySep 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 14 YEAR 4 MONTHS POST OP. THE PATELLA WAS WORN OUT. 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 . PRODUCT NOT RETURNING: IT WAS DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 20318577 ↗
• InjuryJun 26, 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 10 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 19616177 ↗
• InjuryApr 16, 2024Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 76 YEAR OLD FEMALE PATIENT HAD AN INITIAL TKA IN 2010. THE PATIENT HAS BEEN EXPERIENCING SWELLING, PAIN, AND WHAT FELT LIKE A POKING SENSATION IN HER KNEES. X-RAY STUDIES SHOWED A SLIGHT INCLINATION IN THE TIBIAL IMPLANT. WE HAVE REGULARLY MONITORED THE X-RAY REPORTS WHICH SHOWED WORSENING. THE PATIENT WAS REVISED FOR SUSPECTED OSTEOLYSIS. ADDITIONAL DETAILS PENDING.

  Patient problems: Deformity/ Disfigurement; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19122557 ↗
• InjuryApr 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2017 APPROXIMATELY 6 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19095061 ↗
• InjuryMar 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18824340 ↗
• InjuryJan 5, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 12 YEARS AND 1 MONTH 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 ON (B)(6) 2022. DIAGNOSIS: FAILED LEFT TOTAL KNEE . THERE WAS OBVIOUS FRAGMENTATION OF THE POLYETHYLENE INSERT WITH MULTIPLE LOOSE FRAGMENTS OF THE POLYETHYLENE PRESENT. THE POST HAD FRACTURED OFF. SYNOVECTOMY WAS PERFORMED INVOLVING THE PATELLOFEMORAL COMPARTMENT AS WELL AS THE MEDIAL AND LATERAL GUTTERS. THERE WAS WEAR NOTED ABOUT THE PATELLA BUT THE BUTTON WAS WELL FIXED AND THERE WAS LEFT IN SITU. THE POLYETHYLENE INSERT WAS REMOVED. THE PATIENT WAS REMOVED FROM THE OPERATING TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis

  MAUDE report 18454471 ↗
• InjuryJan 4, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2007. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) 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 WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18442550 ↗
• InjuryAug 14, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2011. APPROXIMATELY 6 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018. 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 ON (B)(6) 2018 DIAGNOSIS: ASEPTIC LOOSENING OF THE TIBIA WITH LARGE METAPHYSEAL UNCONTAINED BONY DEFECT AND POLYETHYLENE WEAR. THERE WAS A GROSS AMOUNT OF SYNOVITIS AND SYNOVIUM WHERE I HAD TO DO A SUBTOTAL SYNOVECTOMY BOTH SUPERIORLY AND INTO THE MEDIAL AND LATERAL GUTTERS. THE SURGEON DID A STANDARD MEDIAL PEEL AND TOOK OUT A SIGNIFICANT AMOUNT OF SYNOVITIS LATERALLY AND UNDERNEATH THE PATELLA TENDON TO GET THE PATELLA EVERTED. THE TIBIAL COMPONENT WAS GROSSLY LOOSE. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION.

  Patient problems: Aseptic loosening; Failure of Implant; Pain; Scar Tissue; Synovitis

  MAUDE report 17546354 ↗
• InjuryApr 25, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA THE LEGAL DEPARTMENT THE PATIENT UNDERWENT A LEFT KNEE REPLACEMENT (B)(6) 2009. APPROXIMATELY 8 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017 DUE TO PAIN, DISCOMFORT AND INSTABILITY. 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 ON (B)(6) 2017. DIAGNOSIS: LEFT PAINFUL TOTAL KNEE REPLACEMENT THERE WAS A SIGNIFICANT AMOUNT OF SYNOVIAL FLUID. IT WAS NOTED SIGNIFICANT POLY WEAR IN THE MEDIAL COMPARTMENT. THE PATIENT TOLERATED PROCEDURE WELL AND WENT TO THE PACU IN STABLE CONDITION.

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

  MAUDE report 16806428 ↗
• InjuryApr 21, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION OPERATIVE OF 15 JUL 2022-PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. PREOPERATIVE DIAGNOSIS: GLOBAL INSTABILITY STATUS POST LEFT TOTAL KNEE REPLACEMENT, RECURRENT EFFUSIONS AND PAIN. PROCEDURE(S): REVISION LEFT TOTAL KNEE REPLACEMENT, BOTH COMPONENTS. FINDINGS: GLOBAL INSTABILITY UNDER ANESTHESIA WITH 5 DEG HYPEREXTENSION, MED/LAT LAXITY IN EXTENSION MID FLEXION AND FLEXION WITH 1 CM AP TRANSLATION. POST WEAR. COMPONENTS WELL FIXED. AORI TYPE I BONE LOSS TIBIA AND TYPE I BONE LOSS FEMUR. NO GROSS EVIDENCE OF INFECTION. LOOSE POLY INSERT WITHIN THE TRAY CONSISTENT WITH BACKSIDE WEAR. PROCEDURE: SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS FOUND TO BE WELL FIXED AND SO WAS RETAINED DUE TO MORBIDITY OF REMOVAL. THE SIZE 11 MM PS POLYETHYLENE INSERT WAS FOUND TO BE LOOSE ON THE TRAY AND THERE WAS SEVERE WEAR OF THE POST. THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED; THE COMPONENT WAS THEN REMOVED USING A BONE TAMP WITH MINIMAL BONE LOSS. REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI TYPE I BONE LOSS. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED; THE TIBIAL COMPONENT WAS THEN REMOVED. BONY INVENTORY OF THE TIBIA REVEALED AORI TYPE I BONE LOSS. THERE WAS EXCELLENT SUPPORT

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Osteolysis

  MAUDE report 16783990 ↗
• InjuryApr 3, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SIXTEEN YEARS POST INITIAL RIGHT TKA, THE 70 Y/O FEMALE PATIENT JOINT WAS LOOSE. IMPLANTS WERE WELL FIXED. PATIENT WAS REVISED TO A SIZE 2, 15MM POLY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT STABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16665536 ↗
• InjuryFeb 17, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS FEMALE PATIENT'S PS KNEE WAS REVISED 5 YEARS POST OP INITIAL SURGERY. REVISION WAS TO CHANGE THE PATELLA AND ADD A THICKER INSERT.

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

  MAUDE report 16395758 ↗
• InjuryFeb 14, 2023Mechanical Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  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. 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) 2009 AND WAS INSERTED WITH ANOTHER OPTETRAK DEVICE, APPROXIMATELY 11 MONTHS POST INITIAL PROCEDURE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH 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; Aseptic loosening; Discomfort; Implant Pain; Joint Laxity; Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16372602 ↗
• InjuryAug 17, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP THE INITIAL TSA, THIS FEMALE PATIENT WAS BROUGHT BACK FOR LEFT KNEE PAIN. THE POLY INSERT WAS REMOVED WITH SIGNIFICANT WEAR. BOTH IMPLANT WERE FOUND TO BE WELL FIXED. A NEW EXACTECH SIZE 2 15MM INSERT WAS IMPLANTED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15240701 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, 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 10946558 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A (B)(6) PATIENT AT (B)(6) EXPERIENCED A KNEE REVISION SURGERY ON (B)(6)2016, DUE TO INSTABILITY. THE LATERALITY OF THE KNEE REVISED WAS NOT REPORTED. INITIAL SURGERY DATE WAS (B)(6) 2009. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946538 ↗
• InjuryOct 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2011, 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 10760130 ↗
• InjuryOct 12, 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 10661610 ↗

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-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-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-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-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.