Optetrak 208-01-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862053213), received between Feb 13, 2020 and May 20, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K954208); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT WAS INDICATED WITH PAIN AND MECHANICAL FAILURE, SWOLLEN KNEE AND EARLY SIGNS OF OSTEOLYSIS OBSERVED IN (B)(6) OF 2021. SUBSEQUENTLY, IN (B)(6) 2022 THE PATIENT WAS INDICATED WITH MASSIVE OSTEOLYSIS IN BOTH TIBIA AND FEMUR. IN (B)(6) 2023 THE PATIENT UNDERWENT LEFT KNEE REVISION SURGERY. IT WAS NOTED OSTEOLYSIS WAS CONFIRMED, FEMORAL COMPONENT FOUND TO BE LOOSE (AORI TYPE 3). TIBIAL BONE LOSS CLASSIFIED AS AORI TYPE 2A IN THE MEDIAL COMPARTMENT. IT WAS NOTED THAT THE SURGEON ATTEMPTED IMPLANTATION OF JOHNSON & JOHNSON SLEEVES, BUT FIXATION WAS NOT ACHIEVED. ULTIMATELY, A LINK HINGE PROSTHESIS WITH METAPHYSEAL CONES WAS IMPLANTED. PATIENT WAS REVISED TO A COMPETITOR'S CONSTRUCT. IT WAS REPORTED THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO PATIENT IMPACT OR OUTCOME WAS REPORTED. A PHOTO OF THE EXPLANTED INSERT WAS PROVIDED. NO X-RAYS WERE OBTAINED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 22054853 ↗
• InjuryMay 4, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2010. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD THE FIRST LEFT KNEE REVISION ON 15 DEC 2016. APPROXIMATELY 6 MONTHS AFTER THE FIRST LEFT KNEE REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2017. AFTER EACH OF THE LEFT TOTAL KNEE REPLACEMENT SURGERIES, PLAINTIFF BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH THE DEFECTS OF EXACTECH KNEE SYSTEM AS ALLEGED IN THIS COMPLAINT, INCLUDING BUT NOT LIMITED SO SYNOVITIS WITH ASEPTIC LOOSENING, MECHANICAL LOOSENING, PAIN AND LACK OF MOBILITY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Failure of Implant; Pain; Synovitis

  MAUDE report 16869484 ↗
• InjuryOct 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST BILATERAL TKA, FEMALE PATIENT HAD A REVISION DUE TO FEMORAL LOOSENING. THE FEMUR WAS LOOSE DUE TO NOT ENOUGH CEMENT IN THE CANAL TO HOLD THE STEM IN PLACE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15620186 ↗
• InjuryFeb 13, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE LEFT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS PREVIOUS TRAUMA. ON (B)(6) 2014, APPROXIMATELY 30 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY AND WEAR OF POLYETHYLENE COMPONENT. THE 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. TOTAL KNEE REPLACEMENT INSTABILITY IS NOTED TO OCCUR DUE TO SURGICAL TECHNIQUES OF CREATING EXCESSIVE FLEXION GAPS, INADEQUATE FILLING OF THE EXTENSION SPACE DUE TO THE COMPONENTS NOT BEING THICK ENOUGH, SOFT TISSUE/LIGAMENT DAMAGE, AND/OR INJURY INCURRED DURING POST-OP REHABILITATION THERAPY. MUSCULOSKELETAL KEY, (2018, OCTOBER). TREATMENT OF INSTABILITY AFTER TOTAL KNEE REPLACEMENT; ELECTRONIC SOURCE.

  Patient problems: Failure of Implant

  MAUDE report 9706476 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• 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-