Optetrak 244-03-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862063854), received between Feb 14, 2020 and Dec 17, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K033883); 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE IMPLANT FAILED CLINICALLY, RESULTING IN MAJOR BONE OSTEOLYSIS AND NECESSITATING REVISION SURGERY. EVERYTHING WAS FINE UNTIL ABOUT 1.5 YEARS AGO WHEN PAIN, EFFUSION AND DECREASED MOBILITY BEGAN. X-RAY SHOWING OSTEOLYSIS OF THE POSTERIOR CONDYLES; COMPARING THIS X-RAY WITH THE ONE FROM 2019, DEGENERATION IS EVIDENT. RADIOLUCENT LINES ARE SEEN SURROUNDING BOTH COMPONENTS, WHICH SHOULD BE EVALUATED CLINICALLY (POSSIBLE LOOSENING?). BONE BIOPSIES AND MICROBIOLOGICAL AND HISTOLOGICAL STUDIES RULE OUT INFECTION. INFECTIOUS COMPLICATION; FALL; PRESSURE ULCER; SURGICAL WOUND INFLAMMATION; REINTERVENTION. REMOVAL OF PTJ DTA WITH FINDINGS OF EXTENSIVE SYNOVITIS AND MASSIVE TIBIAL AND FEMORAL OSTEOLYSIS AND REVISION ARTHROPLASTY WITH CEMENTED TIBIA AND FEMORAL SLEEVE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. THE PATIENT SUFFERED PERMANENT DISABILITY AS DIRECT RESULT OF THIS EVENT.

  Patient problems: Fall; Loss of Range of Motion; Radiolucent Lines; Skin Inflammation/ Irritation; Synovitis

  MAUDE report 23827463 ↗
• InjuryNov 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 198 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND MAY REQUIRE A FUTURE REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION INDICATED A REVISION OCCURRED. FEMORAL KNEE DEBONDING/LOOSENING AND PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC RIGHT KNEE JOINT REPORTED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 23648894 ↗
• InjuryApr 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 62 Y/O MALE HAD A PREMATURE POLYETHYLENE WEAR AND DELAMINATION OF INSERT RESULTING IN GRANULOMA AND MASSIVE OSTEOLYSIS WITH LOOSENING OF FEMORAL COMPONENTS AND SIGNIFICANT BONE DEFECTS MEDIAL AND LATERAL FEMORAL CONDYLES. PATIENT REVISED TO COMPETITOR'S COMPONENTS WITH SLEEVES AND STEM EXTENSIONS AND ALLOGRAFT BONE GRAFTING TO FEMUR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. IMAGE RECEIVED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY HOSPITAL.

  Patient problems: Granuloma; Osteolysis

  MAUDE report 21773688 ↗
• InjuryDec 29, 2023Naturally 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)2009. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2016. 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 ALACHUA 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

  Patient problems: Insufficient Information

  MAUDE report 18418294 ↗
• InjurySep 29, 2022Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING BONE LOSS AND SIGNIFICANT SYNOVITIS. PATIENT HAD BEEN COMPLAINING OF MECHANICAL COMPLICATIONS AND CHRONIC PAIN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 15501789 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) (DOB: (B)(6) 1949) PATIENT AT (B)(6) KG EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11009256 ↗
• 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 RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO PAIN. THE REASON FOR PAIN WAS NOT REPORTED. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 10946503 ↗
• InjuryDec 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT A (B)(6) PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO PROSTHESIS FRACTURE. THE PATIENT HAD A BMI OF 40, (B)(6). 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 10946451 ↗
• 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 RIGHT KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2007. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10946436 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, MALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A OPTETRAK HI-FLEX CEMT FEM COMP ASYMMETRIC SIZE 4 RIGHT (CATALOG 244-03-04, SERIAL (B)(4)), OPTETRAK RBK CEMT FINNED TIBIAL TRAY 4F/4T (CATALOG 260-04-44, SERIAL (B)(4)), OPTETRAK POSTERIOR STABILISED RBK TIB INSERT SIZE 4 9MM (CATALOG 264-24-09, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2012, APPROXIMATELY 14. MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING PATELLA. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 35MM.

  Patient problems: Failure of Implant

  MAUDE report 9714969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants