Optetrak Logic 02-010-06-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862265722), received between Mar 2, 2020 and Nov 7, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, EFFUSION WITH SIGNIFICANT LAXITY, SEVERE OSTEOLYSIS, INSTABILITY, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 20631267 ↗
• InjuryApr 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - (B)(6) (B)(4). RELATED CASE (B)(4) (B)(4). EMAIL FROM LEGAL: PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2013. THE PATIENT HAD TWO REVISIONS OF THE RIGHT KNEE (B)(6) 21 AND (B)(6) 22 ***ALL 3 OP REPORTS ARE ATTACHED. OP REPORT (B)(6) 2022. PRE & POST OP DIAGNOSIS: FAILED TOTAL RIGHT KNEE REPLACEMENT INDICATIONS: PATIENT HAD SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF TOTAL RIGHT KNEE REPLACEMENT. PT HAS FAILED CONSERVATIVE TREATMENT AND WISHED TO UNDERGO OPERATIVE INTERVENTION. RISKS, BENEFITS, AND ALTERNATIVES DISCUSSED WITH PATIENT. DESPITE POTENTIAL RISKS, THEY WISHED TO PROCEED WITH THE OPERATIVE INTERVENTION. INTRAOPERATIVE FINDINGS: LOOSE FEMORAL IMPLANT - REMOVED EASILY WITH MINIMAL BONE LOSS BUT CONCERNED FOR BONE QUALITY DISTAL FEMUR. I ELECTED TO SUE FEMORAL CONE. TIBIAL IMPLANT WAS VERY SOLID AND WELL FIXED - BACKSLAP DEVICE AND OSTEOTOMES WERE USED BUT STEM WOULD NOT BUDGE - CORTICAL WINDOW DISTAL TO THE STEM ALLOWED ME TO HIT THE STEM TIP AND KNOCK IT OUT RETROGRADE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 16725637 ↗
• InjuryNov 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, SURGEON REVISED THE FEMORAL COMPONENTS OF A LOGIC CC KNEE THAT HE IMPLANTED ON (B)(6) 2017. DURING THE CASE SURGEON NOTED INCOMPLETE FIXATION OF THE FEMORAL DEVICE. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS REVISED TO EXACTECH COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15820614 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY EIGHT MONTHS POST TKA, THE PATIENT EXPERIENCED PAIN AND INSTABILITY. ON (B)(6) 2017, PATIENT WAS SQUATTING DOWN AND FELT RT. KNEE POP FORWARD AND DISLOCATED. PATIENT'S KNEE WAS MANIPULATED WHILE HE WAS IN (B)(6) AND WAS REDUCED. ON (B)(6) 2018, PATIENT CONTINUED TO HAVE INSTABILITY AND IN (B)(6) 2018 THE KNEE WAS GETTING WORSE BY GIVING AWAY AND PAINFUL. DR. (B)(6) SCHEDULE A REVISION (B)(6) 2018. THE EVENT IS POSSIBLY RELATED TO THE DEVICE BUT UNLIKELY RELATED TO THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE, IT APPEARS THE PATIENT LEFT THE STUDY.

  Patient problems: Failure of Implant

  MAUDE report 12674149 ↗
• InjuryMar 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 3.5 YEARS POSTOP IMPLANTATION, THIS (B)(6) Y/O MALE PATIENT, WHO WEIGHS (B)(6) LBS., WAS REVISED DUE TO ¿FAILED RIGHT TKA, ASEPTIC LOOSENING¿. NO OTHER INFORMATION AVAILABLE. TREATMENT IS NOTED AS RESOLVED. THE EVENT IS DEFINITELY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 9775498 ↗

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