Optetrak Logic 02-010-06-0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862265654), received between Mar 29, 2021 and Feb 29, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 29, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL LEFT TKA, THE SURGEON REVISED A LOGIC CC OF THE PATIENT DUE TO LOOSENING OF THE FEMORAL CONSTRUCT. THE PATIENT EXPERIENCED PAIN, OSTEOLYSIS AND FIBROSIS. THEY WERE REVISED WITH LOGIC CC. THERE WAS NO BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT IMAGE RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Extraskeletal ossification; Failure of Implant; Fibrosis; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue

  MAUDE report 18813022 ↗
• InjuryMay 1, 2023Fitting Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fitting Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 65 YO FEMALE PATIENT EXPERIENCED ASEPTIC FEMORAL LOOSENING WITH PERSISTENT THIGH PAIN RELATED TO MICROMOTION OF FEMORAL STEM WITH INCOMPLETE FIXATION. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2016. INITIALLY TRIED STRENGTHENING EXERCISES AS PATIENT TREATMENT. THE PATIENT WAS REVISED ON (B)(6) 2021 ALONG WITH MEDICATION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2021.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16844502 ↗
• InjuryMar 26, 2023Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 53 YO FEMALE PATIENT HAD AN INCOMPLETE FEMORAL FIXATION. NEAR COMPLETE 1MM RADIOLUCENCY AROUND FEMORAL COMPONENT AND STEM. NO SUBSIDENCE BUT EVIDENCE OF LATERAL CORTICAL HYPERTROPHY AND MOVEMENT OF FEMORAL STEM. REVISION WAS RECOMMENDED. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-UNK. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

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

  MAUDE report 16616956 ↗
• InjuryMar 13, 2023Unstable; Appropriate Device Problem Term/Code Not Available; Unstable; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 52 YO WHITE MALE PATIENT EXPERIENCE PAIN AND OCCASIONAL BUCKLING. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND PAIN MEDICATION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2022.

  Patient problems: Implant Pain; Pain

  MAUDE report 16527320 ↗
• InjuryAug 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YRS POSTOP THE LTKA, THIS (B)(6) Y/O FEMALE PATIENT PRESENTED COMPLAINING OF KNEE PAIN IN THEIR REVISED LEFT KNEE. FEMORAL LOOSENING AND MISALIGNMENT WERE NOTED, AND THE PATIENT WAS SCHEDULED FOR A FEMORAL REVISION. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH A LOGIC CC COMPONENT WITH VARIOUS AUGMENTS ETC. THE TIBIAL COMPONENT WAS WELL FIXED AND WAS NOT REMOVED. THE OPTETRAK FEMORAL COMPONENT AND INSERT WERE REMOVED AND REPLACED WITH LOGIC CC COMPONENTS. DURING TRIALING A 15MM INSERT WAS DEEMED APPROPRIATE. AFTER INSERTION OF THE TIBIAL INSERT THE SURGEON OPTED TO GO UP TO A 17MM INSERT WASTING THE 25. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12329319 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3 YEARS POSTOP THE INITIAL L TKA, THIS (B)(6) Y/O FEMALE PATIENT WAS UNHAPPY WITH HER LEFT KNEE, SO A REVISION WAS DONE WITH SOME CHANGE IN ROTATION. REVISION EXACTECH CC KNEE TO A REVISION EXACTECH CC KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11586364 ↗

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