Optetrak Logic 02-012-48-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862174284), received between Feb 21, 2023 and Sep 3, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 reports).

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

1 other recall cover devices cleared under the same FDA submission (K111400); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 55 MONTHS AFTER A RIGHT 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 20125757 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL TKA, THE PATIENT WAS REVISED DUE TO WEAR ON THE PATELLA AND TIBIAL INSERT. EVERYTHING WAS REMOVED AND REPLACED WITH COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 20085666 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. (B)(4). CASE NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 30 MONTHS AFTER A RIGHT 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20030435 ↗
• InjuryAug 12, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA (MDL NO. 3044) (NGG) (MMH). PATIENT ID: FRANCES VALENE LK REV. 8. PLAINTIFF WAS IMPLANTED WITH THE FOLLOWING EXACTECH DEVICE: KNEE (OPTETRAK/OPTETRAK LOGIC) 9. LEG IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: LEFT. 10. DATE THE EXACTECH DEVICE WAS IMPLANTED (SEE ALSO NOTE TO PARAGRAPH 5 ABOVE): (B)(6) 2014. 11. STATE IN WHICH THE EXACTECH DEVICE WAS IMPLANTED: AL. 12. DATE THE EXACTECH DEVICE WAS SURGICALLY REMOVED/REVISED: (B)(6) 2023 13. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: PLAINTIFF HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH HAS LIMITED HER ACTIVITIES OF DAILY LIVING AND IMPACTED HER QUALITY OF LIFE. PLAINTIFF HAS SUFFERED 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. AS A FURTHER DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE EXACTECH DEVICE, PLAINTIFF HAS SUSTAINED AND WILL SUSTAIN FUTURE DAMAGES, INCLUDING BUT NOT LIMITED

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19962064 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 84 MONTHS AFTER A LEFT 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 19376979 ↗
• InjuryApr 16, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 7 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Anxiety; Emotional Changes; Failure of Implant

  MAUDE report 19122653 ↗
• InjuryOct 25, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA IN 2018. THE PATIENT PRESENTED 5 YEARS LATER COMPLAINING OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. NO METALLOSIS WAS FOUND. THE SURGEON DECIDED THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. ALL PROLIFERATIVE TISSUE WAS REMOVED AND THE INSERT WAS REPLACED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 18008371 ↗
• InjurySep 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: POLYETHYLENE FAILURE. WHEN THEY ENCOUNTERED THE EFFUSION THERE WAS NO PURULENCE. THERE WAS A SLIGHT GRAYISH-BROWN TINGE TO THE SYNOVIUM AND THE SYNOVIUM WAS SEVERELY HYPERTROPHIC AND DID HAVE PLASTIC DEBRIS WITHIN THE SYNOVIUM. POLYETHYLENE INSERT WAS REMOVED. POSTERIOR ASPECTS OF THE POLYETHYLENE WAS FRACTURED AND THE POSTERIOR LIP ANATOMY OF THE POLYETHYLENE WAS ALSO MISSING. THERE WAS NO EVIDENCE OF LOOSENING. THE PATIENT WAS AWOKEN AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint effusion; Pain; Synovitis

  MAUDE report 17699209 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT TKA, THE 68 Y/O FEMALE PATIENT HAD A POLY SWAP FOR AN UNKNOWN REASON. PATIENT WAS REVISED TO EXACTECH DEVICE. 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 X-RAYS OR IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICE WAS KEPT BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 17588050 ↗
• InjuryAug 21, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 67 Y/O FEMALE PATIENT HAD A POLY SWAP FOR AN UNKNOWN REASON. PATIENT WAS REVISED TO EXACTECH DEVICE. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS HOSPITAL RETAINED THE DEVICE. NO OTHER IMPLANT/MEDICAL INFORMATION PROVIDED.

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

  MAUDE report 17587700 ↗
• InjuryJun 20, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL RIGHT TKA, THE 62 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WORN, ALSO INFECTED TISSUE IN PATIENT. LINER WAS EXCHANGED TO A CRC LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 17160056 ↗
• InjuryApr 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT (B)(6) 2014, THIS PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS IN HER LEFT KNEE. THE PATIENT'S EXACTECH TOTAL KNEE ARTHROPLASTY IS FAILING AS A RESULT OF THE FAILURE OF HER OPETETRAK DEVICE IMPLANT, THEY WILL NEED REVISION SURGERY PREMATURELY. 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: Implant Pain; Insufficient Information

  MAUDE report 16823887 ↗
• InjuryMar 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 6 MONTHS POST OP THE INITIAL LEFT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE THE RECALL. SURGEON DID NOT PROVIDE ANY MORE DETAILS ON REASON FOR THE REVISION TO THE REPRESENTATIVE. NO BREAKAGE OF DEVICE OR SURGICAL DELAY PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION MEDICAL HISTORY PROVIDED. UNABLE TO OBTAIN X-RAYS/PHOTOS. PRODUCT NOT RETURNING HOSPITAL WOULD NOT ALLOW.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16649378 ↗
• InjuryFeb 21, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS FEMALE PATIENT'S LEFT KNEE WILL NEED TO A REVISION SURGERY PREMATURELY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Pain

  MAUDE report 16409153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013