Optetrak Logic 02-012-65-4017Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862266149), received between Aug 8, 2020 and Jan 3, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJan 3, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2020, PATIENT UNDERWENT REVISION OF HIS FAILED RIGHT OPTETRAK DEVICE. DURING THE REVISION PROCEDURE, PATIENT¿S SURGEON NOTED DEFECTIVE EQUIPMENT REQUIRING COMPLETE REVISION. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO DEFECTIVE EQUIPMENT ON (B)(6) 2022. UPON INFORMATION AND BELIEF, THE DEFECTIVE OPTETRAK DEVICE FAILED PREMATURELY IN PATIENT¿S RIGHT KNEE. THE POLYETHYLENE COMPONENT USED IN THE OPTETRAK DEVICE WAS DEFECTIVE, LEADING TO EARLY ASEPTIC LOOSENING. A PACKAGING DEFECT IN THE PACKAGING CONTAINING THE OPTETRAK POLYETHYLENE INSERTS ACCELERATED POLYETHYLENE WEAR DUE TO OXIDATION.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 16092560 ↗
• InjuryNov 10, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 75 YO MALE, HAD AN INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2021, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR POST THE INITIAL PROCEDURE DUE TO INFECTION. THE JOINT HAD TO BE OPENED AND DEBRIDEMENT WAS NECESSARY. THE WOUND WAS WASHED OUT AND THE POLYETHYLENE WAS SWAPPED. THERE WERE NO REPORTED ISSUES WITH THE REVISION SURGICAL PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT NOT RETURNING; THE HOSPITAL POLICY WILL NOT ALLOW FOR THE EXPLANT TO LEAVE THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 15770222 ↗
• InjuryAug 8, 2020Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2016, A (B)(6) Y/O, MALE PATIENT WITH A BMI OF 29.5, UNDERWENT IMPLANTATION OF A LOGIC CC TIB INSERT SIZE 4, 17MM. ON (B)(6) 2018, APPROXIMATELY 15 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Joint Laxity; Muscle/Tendon Damage; Osteolysis

  MAUDE report 10383055 ↗

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