Optetrak Logic 02-012-41-2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862003119), received between Dec 4, 2020 and Mar 11, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Migration; Migration

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL AND PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATES A SIGNIFICANTLY LOOSE FEMORAL COMPONENT, SEVERE POLYETHYLENE DEBRIS AND SYNOVITIS WITH PARTICULAR DISEASE, A MEDIALLY WORN POLYETHYLENE PATELLA COMPONENT, WEAR OF THE PS TIBIAL POST OF THE TIBIAL INSERT, AND A FIXED CEMENTED TIBIAL COMPONENT WITH ANTERIOR SUBSIDENCE. THE SURGEON PERFORMED A CEMENTED REVISION RIGHT TOTAL KNEE REPLACEMENT WITH STEM AUGMENTATION. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Cyst(s); Discomfort; Pain; Synovitis

  MAUDE report 21573397 ↗
• InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 169 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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; Balance Problems; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20663442 ↗
• InjuryOct 10, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS MASSIVE POLY WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INDICATION: ASEPTIC LOOSENING IN THE SETTING OF MASSIVE POLY WEAR FROM RECALLED IMPLANT. PROCEDURE DESCRIPTION: IT WAS NOTED THAT THERE WAS HYPERTROPHIC AND METALLIC APPEARANCE OF THE SYNOVIUM. AN EXAMINATION OF THE POLYETHYLENE LINER REVEALED CATASTROPHIC FAILURE OF THE MEDIAL COMPARTMENT LEADING TO METAL ON METAL ARTICULATION. RETRACTORS WERE PLACED AND THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. NEXT THE TIBIA WAS PRESENTED ANTERIORLY AND A THIN CURVED OSTEOTOME WAS USED TO REMOVE THE TIBIAL COMPONENT. THIS AGAIN WAS PERFORMED WITH MINIMAL DIFFICULTY AND MINIMAL BONE LOSS. THERE WAS A SIGNIFICANT CAVITARY LESION IN THE PATELLA THAT WAS DEBRIDED WITH A RONGEUR AND CURETTE. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology; Scar Tissue

  MAUDE report 20422969 ↗
• 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 RIGHT KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2009. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946510 ↗

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-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-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-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.