Optetrak Logic 02-010-06-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862265708), received between Jun 24, 2020 and May 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A REPRESENTATIVE INFORMED THAT ON (B)(6) 2022 THAT A SURGEONS WILL BE REPLACING A LOOSE FEMORAL STEM EXTENSION SCREW IN ONE OF HIS PATIENT'S RIGHT KNEE. THE REVISION TO OCCUR ON (B)(6) 2022. THE X-RAY IMAGES PROVIDED INDICATE THAT THIS IS A LOGIC CC FEMORAL COMPONENT. THE PLAN IS TO RETAIN THE FEMORAL COMPONENT, REMOVE THE LOOSE SCREW, AND REPLACE WITH A NEW SCREW THAT THEY WILL TIGHTEN DOWN INTRAOPERATIVELY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279317 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YRS POSTOP THE INITIAL LTKA, THE (B)(6) Y/O FEMALE PATIENT PRESENTED WITH COMPLAINTS OF PAIN SINCE SURGERY. THE PATIENT STATED, ¿KNEE FEELS LIKE IT IS GOING TO GIVE AWAY¿, AND SHE USES A WALKER AS A RESULT. REVISION COMPLETED. PATIENT DISCHARGED HOME WITH HOME HEALTH AFTER 1 DAY. DEVICES WILL NOT RETURN DUE TO STUDY POLICY.

  Patient problems: Pain

  MAUDE report 11812060 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS FEMALE PATIENT HAS A CHARCOT KNEE (NEUROPATHIC ARTHROPATHY) WHICH IS A DISORDER THAT CAUSES PROGRESSIVE DEGENERATION OF A WEIGHT BEARING JOINT INCLUDING BONY DESTRUCTION, RESORPTION, AND DEFORMITY DUE TO LOSS OF SENSATION. HAD MULTIPLE TOTAL KNEE SURGERIES OVER THE COURSE OF HER LIFE. SHE DEVELOPED AN INFECTION IN HER RIGHT KNEE, AS WELL AS FRACTURED HER TIBIA. DUE TO HER DISEASE AND THE FRACTURE, THE STEM BROKE AT THE TAPER JUNCTION AT THE TIBIAL IMPLANT. THE FEMALE PATIENT ARRIVED AT DR. (B)(6) CLINIC 3 MONTHS PRIOR AFTER A REVISION OF A TOTAL KNEE, TO AN EXACTECH OPTETRAK CCK, WITH A SWOLLEN KNEE. DUE TO HAVING A CHARCOT KNEE JOINT SHE IS UNABLE TO FEEL PAIN AND CONTINUED TO WALK ON WITH A FRACTURED TIBIA, AS SUCH SHE DEVELOPED AN INFECTION AND BROKE HER IMPLANT AT THE TIBIAL STEM TAPER JUNCTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING. THE PATIENT WAS INFECTED, AND ALL IMPLANTS WERE REMOVED, AN ANTIBIOTIC SPACER WAS IMPLANTED. THIS EVENT TOOK PLACE DUE THE CHARCOT JOINT, INFECTION AND OVERALL POOR BONE QUALITY. THESE FACTORS ATTRIBUTED TO THE TIBIAL STEM BREAKING, NOT A MANUFACTURING ERROR, OR SURGICAL ER

  Patient problems: Bacterial Infection

  MAUDE report 10192652 ↗

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