Optetrak Logic 02-012-35-1011Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885862001696), received between Dec 4, 2020 and May 15, 2024 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19325375 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 73 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19324459 ↗
• InjuryApr 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 19103680 ↗
• InjurySep 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2013. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 8 YEARS 10 MONTHS POST PRIMARY SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT. THE PATIENT CLAIMS TO HAVE SUFFERED FROM INJURIES INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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; Balance Problems; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain

  MAUDE report 17729235 ↗
• InjuryAug 15, 2023Naturally 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) 2017. APPROXIMATELY 6 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. 2022 CA 002670. 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 RESUL

  Patient problems: Insufficient Information

  MAUDE report 17547932 ↗
• InjuryJul 5, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2013. THEY WERE SUBSEQUENTLY REVISED ON (B)(6) 2023, APPROXIMATELY 9 YEARS 9 MONTHS AFTER THEIR PRIMARY REPLACEMENT. (B)(6) 2023 OP REPORT FINDINGS: NO GROSS EVIDENCE OF INFECTION. GROSSLY LOOSE PATELLAR COMPONENT WITH SEVERE WEAR. DELAMINATED DISCOLORED POLY INSERT WITH SEVERE POLY WEAR WITH NEAR COMPLETE WEAR THROUGH OF THE POST. GLOBAL INSTABILITY WITH 10 DEG HYPEREXTENSION. VALGUS MALALIGNMENT. DEBONDED FEMORAL COMPONENT. AORI I BONE LOSS TIBIA. AROI IIB BONE LOSS FEMUR PRIMARILY INVOLVING POSTERIOR FEMORAL CONDYLES. SEVERE OSTEOLYSIS PATELLA WITH THIN REMAINING BONE STOCK INADEQUATE FOR REVISION PATELLA RESURFACING. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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.

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

  MAUDE report 17257858 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT ((B)(6) ) WAS IMPLANTED WITH A 02-012-35-1011-INSERTO TIBIAL LOGIC PS 1, 11 MM, SERIAL NUMBER (B)(6) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 01-NOV-2012 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 01-NOV-2012 AND WAS 1.3 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 2017, APPROXIMATELY THREE YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16971060 ↗
• InjuryMay 21, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 02-012-35-1011-INSERTO TIBIAL LOGIC PS 1, 11 MM, SERIAL NUMBER (B)(6), ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON (B)(6) 2013 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2013 AND WAS NINE MONTHS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2020, APPROXIMATELY SIX YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16971035 ↗
• InjuryMay 18, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH UBARMIN HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT ((B)(6)) WAS IMPLANTED WITH A 02-012-35-1011-INSERTO TIBIAL LOGIC PS 1, 11 MM, SERIAL NUMBER 2932094 ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 1/24/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 1/24/2014 AND WAS 0.64887063655030797 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2020, APPROXIMATELY 6.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16955788 ↗
• InjuryMay 17, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (549) WAS IMPLANTED WITH A 02-012-35-1011-INSERTO TIBIAL LOGIC PS 1, 11 MM, SERIAL NUMBER (B)(4) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 20-MAR-2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 20-MAR-2014 AND WAS SIX MONTHS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY NINE YEARS POST IMPLANTATION, THE PATIENT IS PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16950602 ↗
• InjuryApr 26, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT (B)(6) 2015, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HER LEFT KNEE. AT SOME POINT THEREAFTER, THEY PRESENTED FOR EVALUATION CITING MECHANICAL COMPLICATIONS AND CHRONIC PAIN. ON OR ABOUT (B)(6) 2022, APPROXIMATELY 7 YEARS 3 MONTHS AFTER THEIR INITIAL SURGERY, THEY UNDERWENT REVISION SURGERY OF THE LEFT KNEE DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THERE WAS "SEVERE BONE LOSS THAT WAS ENCOUNTERED ON THE TIBIA AND FEMUR" AND THERE WAS "ASEPTIC LOOSENING OF THE LEFT TOTAL KNEE ARTHROPLASTY". THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO FURTHER 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; Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 16815905 ↗
• InjuryApr 12, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL TKA, THE FEMALE PATIENT HAD A FULL REVISION DUE TO CHRONIC HYDRATOSIS, MODERATE MEDIAL LAXITY AND SLIGHT HYPEREXTENSION. SYNOVITIS WAS REMOVED, A FULL LAVAGE WAS PERFORMED, A TISSUE SAMPLING WAS COLLECTED AND TOTAL REVISION COMPLETED. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 16725862 ↗
• InjuryFeb 14, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A FEMALE PATIENT IN HER 80¿S, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2011, INDICATED SHE HAS BEEN EXPERIENCING NUMBNESS AND SWELLING SINCE 2018 WHICH SHE THOUGHT WAS A NORMAL SIDE EFFECT OF THE PROCEDURE DONE IN BOTH HER KNEES. SHE SOUGHT MEDICAL HELP AND WAS GIVEN MEDICATION TO EASE THE PAIN AND THE SWELLING. SHE STILL TAKES PAIN MEDICATION AS OF THIS WRITING. SHE HAS NOT BEEN REVISED, BUT SHE RECEIVED A RECALL LETTER SHOWING THAT SHE HAD BILATERAL IMPLANT SURGERIES. PER HER DAUGHTER, ¿SHE WILL NOT ENDURE ANOTHER KNEE REPLACEMENT SURGERY AND WOULD LIKELY BE OPEN FOR SETTLEMENT.¿ NO FURTHER INFORMATION.

  Patient problems: Numbness; Pain; Swelling/ Edema

  MAUDE report 16375991 ↗
• InjuryFeb 13, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT A PATIENT, UNDERWENT A BILATERAL KNEE REPLACEMENT INITIAL SURGERY ON (B)(6) 2014. THE PATIENT WAS IMPLANTED WITH A OPTETRAK DEVICES. SPECIFICALLY, IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH OPTETRAK STEMS, OPTETRAK PATELLAS, OPTETRAK SCREWS, OPTETRAK TIBIAL TRAYS, AND OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENTS. FOLLOWING THE SURGERY, THE PATIENT BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 8 YEARS POST INITIAL PROCEDURE AND WAS IMPLANTED WITH A DIFFERENT DEVICE. THE PATIENT CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN BOTH OF HER KNEES WHICH LIMITS HER DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16368737 ↗
• InjuryDec 15, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO INSTABILITY. 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 11009296 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A (B)(6) PATIENT AT 54 KG EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2012. THE LATERALITY OF THE SURGERY WAS NOT LISTED; PATIENT DEVICES FOR THE LEFT SIDE WERE USED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946507 ↗
• InjuryDec 4, 2020Unstable; Unstable

  IT WAS REPORTED THAT A (B)(6) YO (DOB: (B)(6)) PATIENT AT (B)(6) KG EXPERIENCED A KNEE REVISION SURGERY ON (B)(6) 2016, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2012. THE LATERALITY OF THE SURGERY WAS NOT LISTED; PATIENT DEVICES FOR THE LEFT SIDE WERE USED. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10946438 ↗

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