Optetrak Logic 02-012-35-3015Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885862001832), received between Oct 30, 2020 and Jan 2, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K033883); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 135 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PROSTHESIS WEAR, AND FAILURE OF IMPLANT. 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: Failure of Implant

  MAUDE report 21054019 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA BULK LEGAL EMAIL (440). PATIENT ID: (B)(6). THE PATIENT HAS RETAINED AN ATTORNEY WHO CONTACTED EXACTECH TO TOLL THE STATUTE OF LIMITATIONS AND PRESERVE THE PATIENT¿S ABILITY TO FILE A LAWSUIT IN THE FUTURE. BECAUSE THE PATIENT HAS RETAINED AN ATTORNEY TO PRESERVE THE RIGHT TO FILE A LEGAL ACTION SEEKING REDRESS FOR ALLEGED PAST SERIOUS INJURY OR FUTURE SERIOUS INJURY ALLEGEDLY STEMMING FROM THE USE OF AN EXACTECH DEVICE, THE PATIENT APPEARS TO ALLEGE THAT THERE IS A PURPORTED DEFICIENCY IN THE DEVICE AND/OR THAT THE PATIENT HAS INCURRED SERIOUS INJURY AS A RESULT OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19832588 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  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 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; Failure of Implant; Osteolysis

  MAUDE report 19500640 ↗
• InjuryMay 13, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 63 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST OP INITIAL SURGERY. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Synovitis

  MAUDE report 19296357 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 19132542 ↗
• InjuryJan 5, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2012. APPROXIMATELY 9 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18454777 ↗
• InjuryOct 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023 DUE TO ACCELERATED AND PREVENTABLE WEAR. 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; Balance Problems; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 17921564 ↗
• InjuryOct 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019 DUE TO ACCELERATED AND PREVENTABLE WEAR. 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; Balance Problems; Discomfort; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 17920217 ↗
• InjuryApr 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY 4.3 YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT PRESENTED WITH PAIN AND SWELLING FOLLOWING TOTAL KNEE ARTHROPLASTY. THE PATIENT HAS HAD SIGNIFICANT SYMPTOMS IN THIS RIGHT KNEE FOR YEARS, BUT THEY CONTINUE TO WORSEN. IMAGING SHOWS SIGNIFICANT OSTEOLYSIS IN BOTH HIS FEMUR AND TIBIA WITH WELL FIXED IMPLANTS. HE ALSO HAS A LARGE EFFUSION. ASPIRATION OF THE KNEE JOINT ON MULTIPLE OCCASIONS HAS SHOWN NO SIGN OF INFECTION. PATIENT HAD A RIGHT KNEE REVISION WHERE POLYETHYLENE LINER WAS REMOVED. THERE WAS A SMALL CRACK IN THE POST OF THE POLYETHYLENE LINER BUT NO FRACTURE FRAGMENTS. THERE WAS SOME VISIBLE PITTING IN THE POLYETHYLENE. THERE WAS MILD OSTEOLYSIS OF THE MEDIAL AND LATERAL FEMORAL CONDYLES, HOWEVER THE CONDYLES AND EPICONDYLES WERE INTACT. THERE WAS A LARGE AMOUNT OF OSTEOLYSIS IN THE TIBIAL PLATEAU WITH AN AREA OF OSTEOLYSIS THAT HAD BROKEN THROUGH THE ANTEROMEDIAL CORTEX AS WELL AS AN AREA OF OSTEOLYSIS THAT HAD BROKEN THROUGH POSTERIORLY. PATIENT REVISED TO COMPETITOR¿S DEVICES. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 16738203 ↗
• InjuryMar 23, 2023Unstable; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Unstable; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 56 YO FEMALE PATIENT EXPERIENCED PREPATELLAR BURSITIS OF THE RIGHT KNEE CAUSING PAIN, SWELLING, AND LOCKING IN RIGHT KNEE JOINT. SMALL JOINT EFFUSION AND PREPATELLAR SUBCUTANEOUS EDEMA WAS NOTED ON THE MRI. THE DATE OF ADVERSE EVENT ONSET IS 09-13-2022. THE TREATMENT RECOMMENDED WAS EXPLORATION OF KNEE JOINT WITH REVISION OF TIBIAL INSERT AND REBALANCING OF KNEE JOINT. THE PATIENT¿S OUTCOME HAS BEEN UPDATED TO RESOLVED BY REVISION SURGERY ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 16606869 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 56 YO FEMALE PATIENT EXPERIENCED DEEP PERONEAL NERVE PALSY AND ACUTE HEMARTHROSIS CAUSING PAIN, SWELLING AND TOE DROP AFTER STRENUOUS THERAPY. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2017. THE PATIENT WAS TREATED WITH KNEE ASPIRATION, IMMOBILIZER, HOLD ON PHYSICAL THERAPY AND SURGICAL EVACUATION OF HEMATOMA. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2018.

  Patient problems: Hemarthrosis; Muscle/Tendon Damage; Pain

  MAUDE report 16605573 ↗
• InjuryJan 4, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  DEVICE WAS RETURNED WITH NO INFORMATION AND REASON FOR THE REVISION WAS NOT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Pain

  MAUDE report 16099374 ↗
• InjuryOct 4, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT THIS 63 YO FEMALE PATIENT'S KNEE WAS REVISED 7 YEARS POST OP. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Joint Laxity; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 15535784 ↗
• InjuryJul 20, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST OP THE INITIAL LEFT TKA, THIS 67 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT BE RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 15064260 ↗
• InjuryOct 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO RANGE OF MOTION/STIFFNESS. 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 10760070 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants