Optetrak Logic 02-012-41-4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862003225), received between Dec 4, 2020 and Feb 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K933610); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Mechanical Problem; Unstable; Detachment of Device or Device Component; Mechanical Problem; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 110 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, JOINT LAXITY, LOSS OF RANGE OF MOTION, OSTEOLYSIS, PAIN, SWELLING/EDEMA, AND SYNOVITIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21401974 ↗
• InjuryMay 24, 2023Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA INFORMATION RECEIVED BY THE LEGAL DEPARTMENT THAT THIS PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN APPROXIMATELY 5 YEARS, 3 MONTHS, SHE HAD THE LEFT KNEE REVISION SURGERY ON (B)(6) 2021. REVISION OPERATIVE REPORT OF (B)(6) 2021. LEFT TOTAL KNEE ARTHROPLASTY ASEPTIC LOOSENING. PATIENT PRESENTED WITH PAINFUL LEFT KNEE AND FOUND TO HAVE CLEAR LOOSENING OF THE TIBIAL COMPONENT RADIOGRAPHICALLY AS WELL AS INSTABILITY. PROCEDURE: PATELLA FOUND TO BE INTACT. THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED. BONY INVENTORY AFTER REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI 3B DEFECTS SECONDARY TO OSTEOLYSIS. THE TIBIAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND EASILY TAMPED OUT. BONY INVENTORY AFTER REMOVAL OF CEMENT REVEALED AORI 2B DEFECTS, WORSE LATERALLY AFFECTING THE METAPHYSIS. TIBIAL BONE LOSS CALLED FOR USE OF A SIZE B CONE. DURING PROCEDURE WITH A COMPETITOR¿S DEVICE THERE WAS A BONE FRACTURE. DRESSINGS WERE APPLIED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. DISCHARGE TO HOME WHEN COMFORTABLE AND PT GOALS ARE MET. HOSPITAL CARE: ADMISSION (B)(6) 2021, DISCHARGE (B)(6) 2021. THERE IS NO OTHER PATIENT DEMO

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Pain

  MAUDE report 16992952 ↗
• InjuryDec 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2016. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933610. One submission often covers many models, so check the product and lot details in each record.

• Z-2155-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
• Z-2156-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
• Z-2158-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
• Z-2157-2024 · Apr 18, 2024 · Open, Classified
  OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-
• Z-2070-2012 · Sep 23, 2011 · Terminated
  Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 2
• Z-0347-05 · Nov 11, 2004 · Terminated
  Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.