Optetrak Logic 02-012-49-2009Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862174314), received between Nov 13, 2020 and Nov 4, 2024 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED APPROXIMATELY 6 YEARS 7 MONTHS POST OP. EVERYTHING WAS REVISED DUE TO WEAR ON PATELLA AND TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 20605640 ↗
• InjuryJul 12, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  AFTER ABOUT 6 YEARS LATER FROM A PRIMARY SURGERY ON (B)(6) 2018, THE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE ++ TIBIAL INSERT COMPLAINED ABOUT KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE INSERT ONLY WAS REPLACED TO NEW CR ONE WITH 9MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 19728261 ↗
• InjuryJun 19, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT RIGHT KNEE WAS REVISED. ABOUT 6 YEARS LATER FROM A PRIMARY SURGERY, THE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE ++ TIBIAL INSERT COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. ALSO, HE DID NOT FOUND OUT METALLOSIS. HE DECIDED THAT NO PROBLEM OF LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND, AND REMOVING ALL PROLIFERATIVE TISSUES, THE INSERT ONLY WAS REPLACED TO NEW CRC ONE WITH 9MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - A RETRIEVED INSERT WOULD BE USED FOR CLARIFICATION TO A PATIENT.

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

  MAUDE report 19571137 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 9 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE NOT PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19510048 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19286856 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 73 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR. THE ORIGINAL IMPLANTED CR POLY INSERT SHOWED SIGNS OF WEAR ON X-RAY. THE AFFECTED POLY WAS REMOVED AND REVISED TO A CRC SIZE 2, 9MM COMPONENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, UNABLE TO OBTAIN FROM FACILITY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Insufficient Information; Muscle Weakness/Atrophy; Pain; Scar Tissue

  MAUDE report 19274836 ↗
• InjuryMar 25, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 7 YEARS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. *

  Patient problems: Failure of Implant; Joint Laxity; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 18967268 ↗
• InjuryDec 11, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS 75 Y/O FEMALE RETURNED SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR RIGHT TKA APPROXIMATELY 6 YEARS POST OP. THE PATIENT HAD A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY INSERT SWAP AND PATELLA IMPLANT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 18301131 ↗
• InjurySep 5, 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) 2015. APPROXIMATELY 8 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.

  Patient problems: Failure of Implant; Insufficient Information; Osteolysis; Synovitis

  MAUDE report 17681731 ↗
• InjuryAug 31, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2019. APPROXIMATELY 1 YEAR AND 5 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 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: Insufficient Information

  MAUDE report 17661046 ↗
• InjuryJul 6, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6)2017. THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN AND THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE SURGEON DID NOT FIND METALLOSIS. HE DECIDED THAT NO PROBLEM OF THE LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND AND REMOVED ALL PROLIFERATIVE TISSUE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION.

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

  MAUDE report 17265611 ↗
• InjuryApr 6, 2023Naturally Worn; Naturally Worn

  AS REPORTED, AFTER ABOUT 5 YEARS LATER FROM A PRIMARY SURGERY, THE 81 Y/O FEMALE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE ++ TIBIAL INSERT COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. ALSO, HE FOUND OUT METALLOSIS. HE DECIDED THAT NO PROBLEM OF LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND, AND REMOVING ALL PROLIFERATIVE TISSUES, THE INSERT ONLY WAS REPLACED TO NEW ONE. POLYETHYLENE PARTICLES AND PROLIFERATIVE (GROWTH) TISSUES ON THE SURGICAL FIELD WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WAS NO SURGICAL DELAY/PROLONGATION. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RETRIEVED INSERT WOULD BE USED FOR CLARIFICATION TO A PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 16696044 ↗
• InjuryOct 26, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2013. THE PATIENT WAS REVISED ON (B)(6) 2022. THE SURGEON OPENED THE KNEE JOINT, PERFORMED A SYNOVECTOMY, AND REMOVED ANY SCAR TISSUE. THE SURGEON THEN EXAMINED THE IMPLANTS, NOTING THAT THE PATELLA HAD SUBSTANTIAL WEAR. AN OSTEOTOME AND REMOVAL TOOL WERE USED TO REMOVE THE POLY. THE IMPLANT SHOWED TO BE BROKEN AND IN PIECES POSTERIORLY. IT SHOWED DELAMINATION AND PITTING. THE POLY REMNANTS WERE REMOVED AND THE KNEE WAS IRRIGATED WELL. THE METAL IMPLANTS WERE WELL FIXED.

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

  MAUDE report 15675547 ↗
• InjuryApr 7, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POSTOP THE INITIAL IMPLANT, THIS (B)(6) Y/O FEMALE PATIENTS L TKA WAS REVISED DUE TO RADIOGRAPHIC FINDINGS OF WEAR THAT WAS CONFIRMED IN SURGERY. FEMUR, INSERT AND TIBIA WERE REMOVED AND REPLACED WITH BIOMET 360 REVISION COMPONENTS. TIBIA TRAY SHOWED SIGNS OF WEAR ON POSTERIOR MEDIAL SIDE. POLY SHOWED SIGNS OF WEAR ON POSTERIOR MEDIAL AND LATERAL SIDES. DEVICES WAS SENT TO SURGEON¿S PREFERENCE FOR EVALUATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. CONCOMITANT MEDICAL PRODUCTS: LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (CAT# 02-012-45-2020 / SERIAL# (B)(4)). LOGIC CR FEMORAL CEM, LEFT SZ 2 (CAT# 02-010-03-0220 / SERIAL# (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 11628548 ↗
• InjuryNov 13, 2020Naturally Worn; Naturally Worn

  FEMALE, AGE (B)(6), BMI MORE THAN 35, INITIAL IMPLANT OF LEFT KNEE (B)(6) 2018. (B)(6). MR. (B)(6), OUR DIRECT SALES REP. WAS CONSULTED BY DR. (B)(6) ON (B)(6) 2020 ABOUT THIS REVISION CASE FOR THE CASE THAT PRIMARY LOGIC CR SLOPE TKA WAS PERFORMED ON (B)(6) 2018. EXCESSIVE POLYETHYLENE WEAR ON THE MEDICAL COMPARTMENT OF THE LEFT INSERT WAS OBSERVED ON THE PREOPERATIVE X-RAYS, THE REVISION SURGERY FOR REPLACING THE TIBIAL INSERT WAS IMPLEMENTED ON (B)(6) 2020. THE SURGERY WAS FINISHED WITHOUT ANY PROBLEM. SURGEON WILL BE MONITORING POST-OPERATIVE OUTCOME. AT THE TIME OF THE SURGERY, DR. (B)(6) OBSERVED SEVERELY DAMAGED TIBIAL INSERT AS FOLLOWS; 1. REMARKABLE DELAMINATION WEAR ON THE BOTH MEDIAL AND LATERAL ARTICULATING SURFACES. 2. COMPLETELY WORN OUT POSTERIOR ARTICULATING SURFACES. 3. CLACKS AT THE POSTERIOR UNDER CUT AREA FOR LOCKING MECHANISM. 4. BREAKAGE OF THE CENTRAL MUSHROOM PEG FOR LOCKING MECHANISM ON THE BACKSIDE. 5. BROKEN FRAGMENTS WAS ALREADY OBSERVED IN THE PATIENT WOUND SITE WHEN THE SURGEON OPENED THE KNEE JOINT. HE HAS EXPERIENCED SIMILAR SEVERE POLYETHYLENE WEAR OF THE CR SLOPE++ INSERTS IN OTHER CASE, THEN WE SUBMITTED THE EXPERIENCE REPORT ((B)(4)) ON (B)(6) 20

  Patient problems: Failure of Implant

  MAUDE report 10837207 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 16 MONTHS THIS (B)(6) Y/O MALE PATIENT FELL, AND THE CUP WAS KNOCKED LOOSE. DURING A REVISION, THE ENTIRE RIGHT ACETABULAR SIDE, AND THE FEMORAL HEAD, WERE EXPLANTED, HOWEVER ONLY THE FEMORAL HEAD WAS REPLACED WITH AN EXACTECH HEAD. ALL OTHER EXPLANTED COMPONENTS WERE REPLACED WITH COMPETITOR¿S PRODUCTS. DEVICES NOT RETURNING AS THE HOSPITAL THREW AWAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Injury

  MAUDE report 10837206 ↗

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