Optetrak 234-02-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862063205), received between Feb 14, 2020 and Nov 25, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).

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.

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.

• InjuryNov 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. THE FEMORAL KNEE HAD DEBONDED/LOOSENED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED. PREVIOUSLY REPORTED UNDER E-SUBMITTER MDR#1038671-2020-10221.

  Patient problems: Aseptic loosening

  MAUDE report 23641403 ↗
• InjuryDec 6, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 99 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, MENTAL AND EMOTIONAL DISTRESS. THE PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE LEFT KNEE AT ISSUE. 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; Discomfort; Joint Laxity; Osteolysis; Pain

  MAUDE report 20865157 ↗
• InjuryJun 6, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  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 19476064 ↗
• InjuryJun 22, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WAS REVISED DUE TO FEMUR LOOSENING. PATELLA EXCHANGE DUE TO "PATELLA BAJA". THERE IS NO HISTORICAL DATE REGARDING THE INITIAL IMPLANT AVAILABLE. THE FEMUR WAS LOOSE AND REPLACED BY A CC LOGIC OFFSET COUPLER AND A 18X120MM STEM, WITH A PSC INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO IMPLANTS WERE DISPOSED BY HOSPITAL. ADDITIONAL INFORMATION RECEIVED INDICATES THAT BOTTOM RIGHT CORNER, THE METAL THAT HAS EMBEDDED INTO THE POLY FROM THE CLASSIC TIBIAL TRAY WHERE THE CAPS FOR THE AUGMENTS SIT.

  Patient problems: Failure of Implant

  MAUDE report 12045831 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10946493 ↗
• 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 LEFT KNEE REVISION SURGERY ON (B)(6) 2008, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2008. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10681570 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PREVIOUSLY REPORTED, A MALE, (B)(6), RECEIVED A TKA IN THE PAST. THE PATIENT RETURNED WITH AN INFECTION AND IT WAS DECIDED THAT A TWO-STAGE REVISION SHOULD OCCUR. THE FIRST STAGE OF THIS CASE INVOLVED REMOVING THE OLD PROSTHESIS AND IMPLANTING A NEW TIBIA AND FEMUR AS A SPACER WITH ANTIBIOTICS ADDED TO THE CEMENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNED DUE TO FACILITY POLICY. AS REPORTED THE PATIENT RETURNED TO THE OFFICE 6 WEEKS AFTER THE ANTIBIOTIC SPACER WAS INSERTED AND THE SECOND STAGE WAS PLANNED. (CURRENT EVENT, (B)(6) 2020) TWO DAYS AFTER THE 6 WEEKS CHECK, THE PATIENT HAD A FEVER, A WASH OUT WAS DONE, AND SECOND SPACER WAS IMPLANTED. SINCE THE INFECTION RETURNED, IT WAS DECIDED TO USE THE INTERSPACE ANTIBIOTIC SPACER. THE SURGEON WANTED TO USE ANOTHER FEMUR/ALLPOLY FOR THIS STAGE BUT DECIDED TO SETTLE ON THE INTERSPACE ANTIBIOTIC SPACER. ALL WENT GREAT AND WE ARE AWAITING THE SECOND STAGE. THE LARGE INTERSPACE KNEE SPACER WAS IMPLANTED PERFECTLY. THE KNEE WAS VERY STABLE AND BALANCED AWAITING THE SECOND STAGE OF THE REVISION. DEVICE NOT RETURNING. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. CO

  Patient problems: Bacterial Infection

  MAUDE report 10560332 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, 183 CM, (B)(6) (BMI=27), MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2012. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2014, APPROXIMATELY 18 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9712862 ↗