Optetrak Logic 02-012-65-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862266125), received between Jun 20, 2022 and Oct 2, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 73 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PLAINTIFF MICHAEL CANTERBURY IS CURRENTLY SUFFERING FROM THE FOLLOWING COMPLICATIONS, INJURIES AND/OR INDICATIONS, SOME OR ALL OF WHICH MADE REVISION MEDICAL NECESSARY: PAIN, DISCOMFORT, DIFFICULTY WALKING AS A RESULT OF THE DEFECTIVE NATURE OF THE EXACTECH KNEE REPLACEMENT SYSTEM. PLAINTIFF HAS SUFFERED AND MAY CONTINUE TO SUFFER, SEVERE AND PERMANENT PERSONAL INJURIES, INCLUDING POLYETHYLENE WEAR AND DEVICE FAILURE, DISBURSEMENT OF THE POLYETHYLENE LINER INTO BONE AND OTHER BODILY STRUCTURES, PAINFUL KNEE REVISION SURGERIES TO REMOVE OR REVISE THE DEFECTIVE DEVICE, CONTINUED REHABILITATION, MEDICAL CARE AND POSSIBLY ADDITIONAL SURGERIES. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 20353410 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY 4.5 YEARS POST INITIAL TKA, THE 57 Y/O MALE PATIENT COMPLAINT OF LATERAL KNEE PAIN WITH MOVEMENT AND ACTIVITY AND ALSO LOCKING. THE EVENT IS STILL ONGOING. PER CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Pain

  MAUDE report 14750656 ↗

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