Optetrak Logic 02-012-49-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862174536), received between Jul 25, 2023 and Feb 3, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY (TKA) ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND SWELLING. AS A RESULT, THE PATIENT WAS REVISED. UPON REVISION IT WAS FOUND THAT THE TIBIAL IMPLANT SEEMED TO BE DELAMINATING AND WORN SPECIFICALLY ON THE MEDIAL POSTERIOR ASPECT OF THE IMPLANT. THE THREE-PEG PATELLA DIDN'T APPEAR TO SHOW SIGNS OF MUCH DEFORMATION OR DELAMINATION BUT WAS REMOVED SINCE IT WAS A RECALLED IMPLANT. THE WOMB WAS DEBRIDED AND A LARGE VOID WAS NOTICED IN THE DISTAL FEMUR WHERE THE IM ROD WAS PLACED IN THE INITIAL TKA, LIKELY DUE TO OSTEOLYSIS. THE VOID WAS DEBRIDED AND FILLED WITH ABX BONE CEMENT. THE SURGEON REVISED THE TIBIAL LINER AND THE THREE PEG PATELLA AND REPLACED THE IMPLANTS WITH ACTIVIT-E TRULIANT IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24249220 ↗
• InjuryJun 12, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 10 YEARS 2 MONTHS POST INITIAL OPERATION. THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY (TKA) THAT HAD PROGRESSIVE PAIN AND SWELLING IN HIS KNEE. RADIOGRAPHS SHOWED ASYMMETRIC POLYETHYLENE WEAR WORN DOWN TO METAL. ARTHROTOMY INCISION WAS MADE THROUGH EXISTING INCISION AND 100ML OF JOINT FLUID CAME POURING OUT OF THE JOINT. THERE WAS SYNOVITIS WITH (>2CM) PLASTIC FRAGMENTS FLOATING AROUND IN THE KNEE. POLY WAS REMOVED WHICH SHOWED EXTENSIVE WEAR. SYNOVECTOMY WAS PERFORMED; KNEE WAS IRRIGATED A NEW POLY WAS PLACED AND THE KNEE WAS CLOSED IN ROUTINE FASHION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22192768 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  LEGAL CASE-USA PATIENT ID: (B)(6). THIS PATIENT HAS A VERIFIED RIGHT KNEE REPLACEMENT ON THE MASTER LIST WITH DR. (B)(6) AT (B)(6). NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. OPERATIVE REPORT FROM REVISION SURGERY ATTACHED. NO FURTHER INFORMATION. SERIAL NUMBER ITEM NUMBER AND FULL DESCRIPTION (B)(6) 02-012-49-4013 - LOGIC CR TIB INSERT SLOPE++, SZ 4, 13MM ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K111400. CONCOMITANTS: (B)(6) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T (B)(6) 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4 (B)(6) 200-02-32 - THREE PEG PATELLA 32MM.

  Patient problems: Discomfort; Pain; Synovitis

  MAUDE report 20137515 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO.(B)(4). (B)(4) IS ASSOCIATED WITH THIS CASE. 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, AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20002624 ↗
• InjuryMay 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS, 11 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19388736 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 57 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: Insufficient Information

  MAUDE report 19322688 ↗
• InjuryMar 14, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, THE 71 Y/O MALE PATIENT HAD AN ORIGINAL EXACTECH TOTAL KNEE REPLACEMENT. THE EXACTECH KNEE CONFIRMED BY X-RAY. THE PATIENT RETURNED TO SURGEON'S OFFICE COMPLAINING OF PAIN, SWELLING, AND INSTABILITY OF THE LEFT TOTAL KNEE. THE POLYETHYLENE INSERT IS A RECALLED LINER SHOWING WEAR ON IMAGING. THE PATIENT WAS SCHEDULED FOR A KNEE REVISION AND POSSIBLE POLY EXCHANGE. THE PATIENT UNDERWENT A COMPLETE REVISION OF THEIR LEFT TOTAL KNEE TO COMPETITOR'S REVISION TKA IMPLANTS. THE EXACTECH POLY INSERT WAS WORN, THE EXACTECH FEMORAL COMPONENT WAS LOOSE AND DISENGAGED FROM THE FEMUR BONE, AND THE EXACTECH TIBIA COMPONENT ON X-RAY SHOWED LOOSENING ALONG THE PROXIMAL MEDIAL AND LATERAL SIDE. ALL IMPLANTS WERE REMOVED. THE PATIENT LEFT THE OR STABLE FOLLOWING THE TOTAL REVISION OF THEIR LEFT TKA. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A 30-45 MINUTES SURGICAL DELAY/PROLONGATION WITH NO ADVERSE EVENTS AS A RESULT DUE TO THE SURGEON ANTICIPATED DOING A POLY SWAP BUT DUE TO THE LYSIS AND LOOSE COMPONENTS A TOTAL REVISION WAS REQUIRED, WHICH TOOK LONGER THAN THE ORIGINAL ANTICIPATED PLAN OF ACTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAY

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

  MAUDE report 18904115 ↗
• InjurySep 25, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED A 65 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 6 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL KNEE REVISION. THE TIBIAL INSERT AND THE PATELLA WERE REVISED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT RETURNING FOR EVALUATION. THEY WERE SENT TO THE HOSPITAL LAB AND LEGAL DEPARTMENT. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17807411 ↗
• InjuryJul 25, 2023Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6), 2017. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT WAS REVISED ON (B)(6), 2023 AND THE POLY INSERT AND PATELLA WERE SWAPPED. THE POLY TIBIAL INSERT WAS BROKEN IN PIECES POSTERIORLY AND THOSE PIECES WERE REMOVED AND THE KNEE JOINT WAS IRRIGATED. ALL FRAGMENTS, PARTS, OR PIECES WERE REMOVED. 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17393992 ↗

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