Optetrak Logic 02-012-47-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885862174345), received between Mar 6, 2023 and Sep 8, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Naturally Worn” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. APPROXIMATELY FIVE YEARS AND SEVEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION FOR AN UNKNOWN REASON. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22992126 ↗
• InjuryMay 12, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT NEEDED TO BE REVISED BECAUSE OF THE WRONG PACKED LINERS AND WEAR OF THE LINER. SOME PIECES BROKE APART FROM THE LINER AND WERE REMOVED. THE PATIENT EXPERIENCED SWELLING AND PAIN. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22002024 ↗
• InjuryJan 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 44 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND OSTEOLYSIS. 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; Osteolysis

  MAUDE report 21178912 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 37 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN & INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20169233 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 74 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, DISCOMFORT, SWELLING, GAIT IMPAIRMENT, POOR BALANCE AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Emotional Changes; Pain; Swelling/ Edema

  MAUDE report 20146271 ↗
• InjuryAug 12, 2024Naturally Worn; Naturally Worn

  AS REPORTED, 6 YEARS AND 2 MONTHS POST THE INITIAL BILATERAL TKA, A BONE SCAN SHOWED LOW LEVEL HEAT ON BOTH KNEES. THE SURGEON REMOVED THE POLY TIBIAL INSERTS AND LEFT SIDE PATELLA, WHICH ALL SHOWED EVIDENCE OF WEAR AND MILD OSTEOLYSIS. 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: Osteolysis

  MAUDE report 19964119 ↗
• InjuryAug 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 68 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: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19927999 ↗
• InjuryJul 24, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 62 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, AND DECREASED RANGE OF MOTION; PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES; FUTURE DAMAGES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19819978 ↗
• InjuryApr 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. PER OPERATIVE REPORT DATED (B)(6) 2023: INTRAOPERATIVE FINDINGS SHOWED SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR DEBRIS; VISUAL INSPECTION OF THE IMPLANT SUGGESTED SOME POSTERIOR MEDIAL WEAR BUT SURFACE FINDINGS WERE MILD COMPARED TO THE DEGREE OF DEBRIS FORMATION. FEMORAL TIBIAL AND PATELLAR COMPONENTS WERE IN GOOD POSITION AND WELL FIXED.

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

  MAUDE report 19029985 ↗
• InjuryNov 14, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT IN 2017. APPROXIMATELY 6 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT 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. (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 E

  Patient problems: Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 18131410 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE SURGEON REMOVED ALL IMPLANTS FROM THE 61 Y/O FEMALE PATIENT AND REPLACED THEM WITH COMPETITOR'S DEVICES. THE SURGEON REFUSED TO HAVE ANY SALES REP ATTENDED THE CASE. THEREFORE, REASON OF REVISION IS UNKNOWN. 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 DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED BY THE HOSPITAL. .

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18121689 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 71 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED. REASON FOR REVISION WAS NOT REPORTED. SURGEON REMOVED A LOGIC, SIZE 3, 9MM, CR NEUTRAL INSERT. HE REPLACED WITH A TRULIANT, SIZE 3, 12MM CRC INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED. PRODUCT NOT RETURNING - PATIENT¿S LEGAL COUNSEL REQUESTED THE PRODUCT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18083233 ↗
• InjuryNov 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. 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: Failure of Implant

  MAUDE report 18070750 ↗
• InjuryOct 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 4 MONTHS 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 DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: FAILED RIGHT KNEE, POSSIBLE ASEPTIC LOOSENING THERE WAS A LARGE AMOUNT OF INFLAMED SYNOVIAL TISSUE THAT WAS REMOVED. THE POLYETHYLENE WAS REMOVED AND THERE WAS SMALL AMOUNT OF PITTING ON THE MEDIAL TIBIAL PLATEAU. THE PATIENT TOLERATED PROCEDURE WELL AND WAS BROUGHT TO RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17919084 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT TKA, THE FEMALE PATIENT HAD A REVISION DUE TO INFECTION. THE LINER WAS EXCHANGED. 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 PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE THE DEVICE WAS DISPOSED AT THE HOSPITAL.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17267371 ↗
• InjuryJun 13, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST OP INITIAL LEFT TKA, THIS PATIENT WAS REVISED DUE TO THE RECALL. SURGEON PERFORMED A POLY SWAP. NO PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING: HOSPITAL KEPT.

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

  MAUDE report 17117836 ↗
• InjuryApr 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT A FEMALE PATIENT HAD A LEFT KNEE ON (B)(6) 2013. APPROXIMATELY 4 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2017. REVISION OP REPORT (B)(6) 2023/ K MCGUINNESS RECEIVED VIA LEGAL 11 APR 2023. IN THE OP REPORT THERE WAS SIGNIFICANT INSTABILITY AND CATASTROPHIC POLY WEAR. THE MEDIAL AND LATERAL GUTTERS WERE DEBRIDED OF SIGNIFICANT POLY DISEASE. PATIENT ARRIVED IN PACU IN STABLE CONDITION WITH NO APPARENT COMPLICATIONS.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16833282 ↗
• InjuryApr 21, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT HAD A REVISION DUE TO PAIN. THERE WAS SOME WEAR AND POSSIBLE OXIDATION OF INSERT WAS NOTED. THERE WERE NO ISSUES WITH SURGERY. A 10 CRC WAS IMPLANTED. EXPLANT NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16785985 ↗
• InjuryMar 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND THE INSERT WAS REPLACED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 16492654 ↗

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