Optetrak Logic 02-012-41-3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862003171), received between Oct 15, 2020 and Feb 18, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018. APPROXIMATELY 3 YEARS AND 7 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 21402492 ↗
• InjuryDec 31, 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 APPROXIMATELY 53 MONTHS AFTER HAVING A LEFT TOTAL KNEE REPLACEMENT THE PATIENT UNDERWENT A REVISION SURGICAL PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN AND INSTABILITY. THE POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING TIBIAL COMPONENT AND OSTEOLYSIS. INTRAOPERATIVELY, THE SURGEON OBSERVED SIGNIFICANT SYNOVITIS, WEAR OF THE POLYETHYLENE LINER AND SIGNIFICANT FIBROUS TISSUE WITH OSTEOLYSIS BENEATH THE FEMORAL COMPONENT. IT WAS NOTED THERE WAS NO EVIDENCE OF INFECTION. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AND EASILY REMOVED AND WITH OSTEOLYSIS BENEATH AT THE MEDIAL ASPECT. THE PATELLA WAS NOTED TO BE WELL FIXED, BUT WITH SOME WEAR WITH OSTEOLYSIS THAT WAS DEBRIDED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 21047217 ↗
• InjuryDec 11, 2024Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 11 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, TISSUE DAMAGE, REVISION SURGERY, INSTABILITY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Joint Laxity; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 20907573 ↗
• InjuryNov 15, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 168 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS, MEDIAL FEMORAL CONDYLE FRACTURE AND SEVERE BONE LOSS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Failure of Implant; Osteolysis

  MAUDE report 20694935 ↗
• InjuryJun 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND DISCOMFORT, LIMITED ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE; FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. 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; Emotional Changes; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 19575192 ↗
• InjuryMay 21, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND BONE FRACTURE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND CONFIRMED THAT THERE WAS BONDING OF THE TIBIAL IMPLANT AT THE KEEL, BUT WAS NOT FIXED AT THE LEVEL OF THE TIBIAL RESECTION. EVIDENCE OF STRESS SHIELDING WAS NOTICED. REVISION IMPLANTS WERE PLACED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 19366298 ↗
• InjuryJun 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT BEGAN EXPERIENCING PAIN IN HI LEFT KNEE PROSTHESIS APPROXIMATELY NINE MONTHS POST IMPLANT. X-RAYS FROM (B)(6) 2013 SHOW LUCENCY AROUND THE TIBIAL TRAY AND PATIENT'S BONE SCAN SHOWED INTENSE UPTAKE OF THE TIBIAL COMPONENT. PATIENT UNDERWENT A REVISION OF HIS LEFT TIBIAL COMPONENT WITH A DIAGNOSIS OF FAILED LEFT TOTAL ARTHROPLASTY SECONDARY TO ASEPTIC TIBIAL LOOSENING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 17112003 ↗
• InjuryDec 15, 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 1/3/2018, DUE TO LOOSENING. INITIAL SURGERY DATE WAS 1/30/2015. THIS PATIENT HAD BILATERAL KNEE ARTHROPLASTY SURGERY, THERE IS NO SIDE OF REVISION SURGERY REPORTED (LEFT SIDED DEVICES ARE USED FOR THE PURPOSE OF THIS COMPLAINT INVESTIGATION). NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11009275 ↗
• 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) 2017, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2015. THIS PATIENT HAD BILATERAL KNEE ARTHROPLASTY, THE SIDE OF REVISION WAS NOT REPORTED; THE LEFT DEVICES WERE USED FOR THE PURPOSE OF THIS COMPLAINT INVESTIGATION. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946518 ↗
• 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) 2014. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946501 ↗
• 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) 2017, 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 10946479 ↗
• InjuryOct 19, 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) 2011, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2010. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10702474 ↗
• InjuryOct 15, 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) 2010, DUE TO 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 10687541 ↗

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-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-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-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.