Optetrak Logic 02-012-47-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862144331), received between May 4, 2022 and Jan 10, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SCAR TISSUE, FAILURE OF IMPLANT, SWELLING/EDEMA, DISCOMFORT, OSTEOLYSIS AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. RIGHT KNEE FEMUR, TIBIA AND POLY COMPONENTS WERE REMOVED AND REVISED TO A COMPETITOR¿S DEVICES. POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE FAILURE. REVISION OF FEMORAL AND TIBIAL COMPONENTS TO A COMPETITOR¿S DEVICES. THE PATIENT PRESENTED WITH PAIN AND SWELLING. X-RAY DEMONSTRATED THAT THE POLYETHYLENE HEIGHT IN HER KNEE HAD DECREASED BY ALMOST 50%, EXTENSIVE BONE REABSORPTION AND OSTEOLYSIS WITH THE ANTERIOR TIBIA BELOW THE TIBIAL BASEPLATE. MRI SHOWED ADVANCED PROGRESSIVE RADIOLUCENCY AROUND THE TIBIAL COMPONENT SUGGESTIVE OF ASEPTIC LOOSENING AND SIGNIFICANT OSTEOLYSIS WITHIN THE MEDIAL FEMORAL CONDYLE. THERE WERE SEVERAL FLAKES OF POLYETHYLENE IN THE KNEE. THE PATELLAR COMPONENT WAS IN GOOD CONDITION WITH NO LOOSENING. NEW DEVICES WERE TRIALED AND IMPLANTED. A COMPRESSIVE KNEE DRESSING AND KNEE IMMOBILIZER WERE APPLIED. THE PATIENT WAS TRANSPORT

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

  MAUDE report 21129921 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS 5 MONTHS POST OP. THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY USING CR SDT TIBIAL INSERT WHICH STARTED CAUSING KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE INFECTION AND WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT WAS PERFORMED. WEAR ON POSTERIOR SIDE WAS OBSERVED. SURGEON DECIDED TO REPLACED TO A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint effusion; Pain; Unspecified Infection

  MAUDE report 20553196 ↗
• InjuryJul 30, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 72 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, OSTEOLYSIS AND FEMORAL COMPONENT LOOSENING. 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: Osteolysis

  MAUDE report 19859739 ↗
• InjuryMar 11, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT AN 82 YO FEMALE PATIENT, INITIAL TOTAL RIGHT KNEE IMPLANTED WITH A STD INSERT ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 5 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON COMPLAINING OF 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. HE DID NOT FIND ANY 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 A NEW NEUTRAL 9MM. THERE WERE POLYETHYLENE PARTICLES AND PROLIFERATIVE GROWTH WHICH WERE RESECTED BY THE SURGEON APPROPRIATELY. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS IT WAS PROVIDED TO THE PATIENT. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 18878676 ↗
• InjuryDec 5, 2023Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO SURGEONS OFFICE WITH PAIN. SIGNIFICANT POLY WEAR WAS NOTED WITH EXCHANGE. NO ISSUES WITH SURGERY. EXPLANT NOT AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Abdominal Pain; Failure of Implant; Pain

  MAUDE report 18265660 ↗
• InjuryMay 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2021, WAS REVISED ON (B)(6) 2023, APPROXIMATELY 1 YEAR 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR. THE INSERT WAS REPLACED. THERE WAS NO SURGICAL DELAYS PROLONGATION DURING THE PROCEDURE. THE EVENT IS NOT RELATED TO A DEVICE BREAKAGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO THE HOSPITAL DISPOSED OF THE IMPLANTS. DEVICE IMAGE PROVIDED. X-RAYS WERE UNABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846251 ↗
• InjuryMay 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, WAS REVISED ON (B)(6) 2023, APPROXIMATELY 2 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR. THE INSERT WAS REPLACED. THERE WAS NO SURGICAL DELAYS PROLONGATION DURING THE PROCEDURE. THE EVENT IS NOT RELATED TO A DEVICE BREAKAGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO THE HOSPITAL DISPOSED OF THE IMPLANTS. DEVICE IMAGE PROVIDED. X-RAYS WERE UNABLE TO BE OBTAINED. NO FURTHER INFORMATION. EVENT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS? YES, BILATERAL INITIAL IMPLANT DATE: ON (B)(6) 2002 (B)(6), ON (B)(6) 2021 (B)(6). PATIENT REVISED TO EXACTECH DEVICES? YES. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: DISPOSED BY HOSPITAL. 6077567 02-012-47-1509 - LOGIC TIBIAL INSERT STD, SZ 1.5, 9 MM. SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K111400. CONCOMITANTS: 6147190 02-010-04-0315 - LOGIC CR FEMORAL POR, RIGHT, SZ 1.5, 3961908 02-012-45-1515 - LGC TIBIAL F

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845392 ↗
• InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY THE LEGAL DEPARTMENT, APPROXIMATELY 2.5 MONTHS POST OP THE INITIAL LEFT TKA, THIS 69 FEMALE PATIENT'S WAS REVISED DUE TO POLYETHYLENE FAILURE. SURGEON WAS ABLE TO REMOVE THE POLYETHYLENE WITHOUT INCIDENT. IT HAD SIGNIFICANT WEAR, MOSTLY ON THE MEDIAL ASPECT OF THE POLYETHYLENE.

  Patient problems: Failure of Implant

  MAUDE report 14944450 ↗
• InjuryJun 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019. PATIENT'S UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022 DUE TO PREMATURE FAILURE OF HIS EXACTECH OPTETRAK TOTAL KNEE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 14824596 ↗
• InjuryMay 4, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT TKA, SURGEON REMOVED THE EXISTING INSERT OF THIS 70 Y/O FEMALE PATIENT AND REPLACED WITH A NEW INSERT. IMO THE FEMUR APPEARED TO BE LOOSE. SURGEON TOOK SAMPLES FOR CULTURE AND ELECTED TO CHANGE ONLY THE TIBIAL INSERT AT THIS TIME. PATIENT WAS REVISED TO A TRULIANT TIB IMP CR INS STD SZ 1.5, 9 MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAY RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO FACILITY WILL NOT RELEASE TO REP. AS OF NOTE" IT APPEARED THAT PATIENT WAS EXPERIENCING CARDIAC ISSUES THAT ACCORDING TO STAFF IN ROOM HAD NOT APPEARED ON THE CARDIAC CLEARANCE".

  Patient problems: Failure of Implant

  MAUDE report 14272675 ↗

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