Optetrak Logic 02-012-41-4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862003232), received between Oct 18, 2019 and Jun 11, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PRELIMINARY AND POSTOPERATIVE DIAGNOSE INDICATED LOOSE LEFT TOTAL KNEE REPLACEMENT. FINDINGS INDICATED A LARGE AMOUNT OF GRAY SYNOVITIS, OSTEOLYSIS, AND NO EVIDENCE OF INFECTION. TIBIA, FEMUR, AND PATELLA WERE REMOVED, THERE WAS NO CEMENT ON THE FEMORAL SIDE OF THE PROSTHESIS OR ON THE TIBIAL SIDE OF THE PROSTHESIS OR ON THE PATELLA. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 22186224 ↗
• InjuryMar 7, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, BALANCE PROBLEMS, DISCOMFORT, JOINT LAXITY, OSTEOLYSIS, PAIN AND SCAR TISSUE. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue

  MAUDE report 21548080 ↗
• InjuryDec 31, 2024Migration; Migration

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, PAIN, JOINT LAXITY, OSTEOLYSIS, SWELLING AND EDEMA.. 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: Failure of Implant; Implant Pain; Osteolysis; Synovitis

  MAUDE report 21047527 ↗
• InjuryNov 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 13 YEARS AND 4 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Synovitis

  MAUDE report 20626203 ↗
• InjuryJun 24, 2024Unstable; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 135 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAREXTENSIVE METRIC WEAR, DELAMINATION. 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Joint Laxity; Joint effusion; Osteolysis

  MAUDE report 19593239 ↗
• InjuryJun 18, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE APPROXIMATELY 12 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WAS NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. POST OPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, MASSIVE OSTEOLYSIS, INSTABILITY, MEDICAL CONDYLE PATHOLOGIC FRACTURE. PER THE OPERATIVE NOTES, A LARGE EFFUSION WAS RELEASED. THERE WAS EXUBERANT SYNOVITIS. THE TIBIAL AND FEMORAL COMPONENTS WERE GROSSLY LOOSE¿ ALL OTHER BONE WAS RESORBED DUE TO OSTEOLYSIS¿ THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. NO COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 19558843 ↗
• InjuryJun 18, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE APPROXIMATELY 12 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WAS NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. POST OPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, MASSIVE OSTEOLYSIS, INSTABILITY, MEDICAL CONDYLE PATHOLOGIC FRACTURE. PER THE OPERATIVE NOTES, A LARGE EFFUSION WAS RELEASED. THERE WAS EXUBERANT SYNOVITIS. THE TIBIAL AND FEMORAL COMPONENTS WERE GROSSLY LOOSE¿ ALL OTHER BONE WAS RESORBED DUE TO OSTEOLYSIS. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. NO COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 19558134 ↗
• InjuryAug 31, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, PATIENT WHO RECEIVED A BILATERAL TKR ON (B)(6) 2017 RETURNED COMPLAINING OF PAIN IN THE RIGHT KNEE. THE TIBIAL COMPONENT APPEARED TO SHOW SIGNS OF LOOSENING. THE PATIENT WAS SCHEDULED FOR A TIBIAL REVISION. THE REVISION WAS PERFORMED ON (B)(6) 2021. THE TIBIAL TRAY AND INSERT WERE REMOVED. THERE WAS BONE LOSS IN THE TIBIA, SO A CONE AND TIBIAL AUGMENTS WERE IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL RETAINS ALL RETRIEVALS.

  Patient problems: Failure of Implant

  MAUDE report 12392262 ↗
• 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) 2016, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946526 ↗
• 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 KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2012, THE SIDE OF KNEE REVISION SURGERY WAS NOT REPORTED; LEFT SIDED DEVICES WERE USED FOR THIS INVESTIGATION. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946461 ↗
• InjuryOct 30, 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) 2012, DUE TO LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2011. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10760123 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2015. THE PATIENT COMPLAINED OF PAIN AND THE TIBIAL TRAY WAS REVISED ON (B)(6) 2019. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL POLICY. UPON FURTHER REVIEW, THE PAIN MAY HAVE BEEN A RESULT OF PATIENT CONDITIONS; HOWEVER, THIS COULD NOT CONFIRM BECAUSE ADDITIONAL INFO WAS NOT AVAILABLE AND THE DEVICES WERE NOT RETURNED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9208723 ↗

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-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-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-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.