Optetrak Logic 02-012-49-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862174413), received between Jun 30, 2020 and Sep 26, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 27 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20310422 ↗
• InjurySep 5, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K111400.

  Patient problems: Emotional Changes; Pain

  MAUDE report 20153208 ↗
• InjuryAug 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 113 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19925040 ↗
• InjuryJul 20, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL LEFT SIDE TKA, THE FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR. PATIENT WAS REVISED INTO A LOGIC PS TKR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED AT THE HOSPITAL, NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17361108 ↗
• InjuryMay 8, 2023Fracture; Unstable; Naturally Worn; Insufficient Device Problem Information; Fracture; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT RIGHT KNEE REPLACEMENT ON (B)(6) 2012. HE HAD RIGHT KNEE REVISION ON (B)(6) 2017. APPROXIMATELY, 4 YEARS 9 MONTHS AFTER THEIR INITIAL REPLACEMENT SURGERY. POSTOPERATIVE DIAGNOSIS: FRACTURED POLYETHYLENE FAILURE WITH POLYETHYLENE DEBRIS RESULTING IN SEVERE SYNOVITIS. LOOSE FEMORAL COMPONENT WAS PRESENT. 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: Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 16886616 ↗
• InjuryApr 3, 2023Fracture; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 55 YO FEMALE, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 4 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION WAS NOT REPORTED. RECALLED POLY INDICATED. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURN ANTICIPATED AS THE HOSPITAL WOULD NOT ALLOW IT TO BE RETURNED.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Implant Pain; Insufficient Information; Joint effusion; Osteolysis; Swelling/ Edema

  MAUDE report 16668552 ↗
• InjuryFeb 22, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 AS THE POLY HAD DELAMINATED. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16419980 ↗
• InjuryFeb 17, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 62 Y/O FEMALE PATIENT WAS REVISED DUE TO WEAR ON IMAGING. THE ORIGINAL POLY IMPLANT IS INVOLVED IN THE RECALL. A POLY SWAP WAS PERFORMED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - THE POLY IMPLANT HAD TO BE TAKEN TO THE LEGAL DEPARTMENT AT THE HOSPITAL FOR HOLD AND EXAMINATION. THE CORPORATE CAN FOLLOW UP WITH THE HOSPITAL ON THE STATUS OF POLY. THE PATIENT REQUESTED TO TAKE THE POLY AFTER IT WAS RELEASED FROM THE HOSPITAL.

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

  MAUDE report 16395844 ↗
• InjurySep 29, 2022Naturally Worn; Naturally Worn

  APPROXIMATELY 5 YRS POSTOP THE INITIAL IMPLANT, THE 77 Y/O FEMALE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, STIFFNESS, AND SWELLING IN LEFT KNEE. AFTER EXAMINATION AND X-RAY OF THE LEFT TKA, THERE IS EVIDENCE OF POLY WEAR AND POOR ALIGNMENT ON THE RADIOGRAPH. THE POLY IMPLANT THAT IS CURRENTLY IN WAS SEARCHED IN THE RECALL DATABASE AND IS A PART OF THE KNEE POLY IMPLANT RECALL. THE ORIGINAL POLY IS ALSO THE SLOPE ++ STYLE. THE PATIENT WAS SCHEDULED FOR A REVISION OF LEFT TKA, A POSSIBLE POLY SWAP FOR (B)(6) 2022. THE SURGEON OPENED THE KNEE, PERFORMED A SYNOVECTOMY, EXAMINED THE IMPLANTS AND HAD QUESTIONS ON IF THE PATELLA OR ANY OF THE EXACTECH PATELLAE ARE A PART OF THE RECALL. AS THE REPRESENTATIVE, I REPLIED NO, THE KNEE, ANKLE, AD OLD HIP POLYS ARE INVOLVED IN THE RECALL. THE SURGEON EXPLAINED THAT THE PATELLA IMPLANT LOOKED POOR OR WEIRD AND ABNORMALLY WORN FOR THE LENGTH OF TIME THAT IT HAS BEEN IMPLANTED. THE SURGEON SAID HE IS NOT CONFIDENT THAT IT IS ONLY A PACKAGING ISSUE FOR THE CAUSE OF POLY FAILURES, BUT POTENTIALLY AN ISSUE WITH THE MANUFACTURING PROCESS ITSELF. THE SURGEON THEN PAID ATTENTION TO THE TIBIAL INSERT POLYETHYLENE. IT WAS REMOVED

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

  MAUDE report 15503203 ↗
• InjuryNov 8, 2021Naturally Worn; Naturally Worn

  AS REPORTED, THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR. THE POLY IS GREATER THAN 5 YEARS OLD AT THE TIME OF IMPLANTATION. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12774181 ↗
• InjuryJun 30, 2020Naturally Worn; Naturally Worn

  APPROXIMATELY 4 YEARS POSTOP THE INITIAL LEFT TKA, THIS (B)(6) Y/O FEMALE PATIENT WITH PATIENT IS 5¿4¿. (B)(6) POUNDS. BMI 37.25, WAS REVISED TO A BADLY WORN POLY INSERT. THE DEVICE WILL BE RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10214723 ↗

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