Optetrak Logic 02-010-06-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862265678), received between Jun 14, 2021 and Dec 6, 2024 — classified as 9 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (K150890); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 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 A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN APPROXIMATELY 6 YEARS 9 MONTHS LATER THE PATIENT HAD A REVISION SURGERY. REVISION OPERATIVE REPORT OF (B)(6) 2022 -PATIENT WAS REVISED TO COMPETITOR'S DEVICES. POSTOPERATIVE DIAGNOSIS: LEFT KNEE-FAILED CONSTRAINED TOTAL KNEE, ASEPTIC LOOSENING FEMORAL COMPONENT, AND OSTEOLYSIS. PATIENT HAD PRESENTED WITH PAINFUL UNSTABLE CONSTRAINED LEFT KNEE. PROCEDURE: THERE WAS EXTENSIVE SYNOVITIS AND A THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED AND WAS NOTED TO HAVE WEAR AND DELAMINATION. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND WAS REMOVED, THERE WAS MARKED FEMORAL OSTEOLYSIS. THERE WAS NO EVIDENCE OF INFECTION. THE TIBIAL COMPONENT WAS REMOVED WITH MARKED OSTEOLYSIS PROXIMALLY. THE PATELLA WAS WELL FIXED, BUT THERE WAS SOME WEAR WITH DELAMINATION, IT WAS REMOVED. THERE WAS SOME PATELLAR OSTEOLYSIS, WHICH WAS DEBRIDED. DRESSINGS WERE APPLIED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS TO BE DISCHARGED HOME WHEN COMFORTABLE AND MET ALL PHYSICAL THERAPY GOALS. THERE IS NO OTHER PATI

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 20871805 ↗
• InjuryAug 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis

  MAUDE report 20048599 ↗
• InjuryJun 18, 2024Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, SYNOVITIS, EXTENSIVE OSTEOLYSIS DUE TO POLY WEAR, POLY WEAR OF INSERT AND PATELLA, PITTING AND DELAMINATION OF THE POLY INSERT, AND BONE LOSS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 19562015 ↗
• InjuryMar 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 62 YO MALE PATIENT EXPERIENCED ASEPTIC FEMORAL LOOSENING RESULTING IN SWELLING AND PAIN. THE PATIENT REPORTED THAT THE LEFT KNEE STARTED FEELING LOOSER. THE MRI CONFIRMED MOVEMENT. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2021. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

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

  MAUDE report 16600555 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  STUDY: EXACTECH CC CLINICAL STUDY; SUBJECT: (B)(6). IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 66 YO MALE PATIENT EXPERIENCED STIFFNESS OF LEFT KNEE. THE DATE OF ONSET IS UNKNOWN. THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE INFECTION. THE PATIENT WAS ALSO TREATED WITH MEDICATION AND PHYSICAL THERAPY. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. 02-010-06-0240 - LOGIC CC FEMORAL SIZE 4, LEFT, 510K: K150890. CONCOMITANT MEDICAL PRODUCTS: 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; 02-012-64-2016 - TRU FLUTED STM EXT 20MM X 160MM BLAST; 02-012-61-6000 - LOGIC OFFSET STEM EXT COUPLER 6MM; 200-02-35 - THREE PEG PATELLA 35MM; 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM; 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; 02-012-66-5000 - METAPHYSEAL TIBIAL CONE, ML57MM.

  Patient problems: Loss of Range of Motion; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 16535096 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 42 YO MALE PATIENT UNDERWENT A KNEE IRRIGATION AND DEBRIDEMENT PROCEDURE DUE TO INFECTION. THE DATE OF EVENT ONSET IS (B)(6) 2018. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2019. THERE WAS NO CASE REPORT FORM INFORMATION PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16527319 ↗
• InjuryNov 29, 2022Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 64 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE FEMORAL COMPONENTS FOR A LOGIC CC KNEE. THE FEMORAL COMPONENTS WERE LOOSE. THE TIBIAL COMPONENTS WERE WELL FIXED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING, NO REASON PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877848 ↗
• InjurySep 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) MALE'S CASE WAS BOOKED AS A FEMORAL REVISION. UPON REMOVAL IT WAS FOUND TO HAVE A LOOSE BODY, POSSIBLY A CAP FROM THE TIBIAL TRAY AUGMENT SCREW HOLE. REVISED TO TRULIENT CCK WITH STEMS UP, AND DOWN AUGMENTS, AND ANTIBIOTIC BEAD KIT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12484289 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) KNEE REPLACEMENT STUDY, APPROXIMATELY 3.5 YEARS POST TKA, THE PATIENT COMPLAINS THAT HIS LEFT KNEE POPS OUT OF PLACE FREQUENTLY. PHONE INTERVIEW DONE. PATIENT WILL NOT COME INTO OFFICE D/T COVID. THE EVENT IS POSSIBLY RELATED TO THE DEVICE OR THE PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 11991471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150890. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-2704-2017 · Apr 7, 2017 · Terminated
  Exactech Optetrak Logic CC 15mm Tibial Augment Screws