Optetrak Logic 02-012-49-2513Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862159236), received between Nov 2, 2022 and May 29, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED STIFFNESS, PAIN, AND DISSATISFACTION WITH THEIR KNEE REPLACEMENT. AS A RESULT, APPROXIMATELY 6 YEARS, 10 MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION TO REPLACE THE TIBIAL POLYETHYLENE AND PATELLAR IMPLANTS. IT WAS DISCOVERED DURING THE REVISION PROCEDURE THAT THE POLYETHYLENE TIBIAL INSERT WAS BROKEN IN PIECES THAT WERE REMOVED FROM THE POSTERIOR ASPECT OF THE KNEE. ALL OF THE PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL PROLONGATION AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22107178 ↗
• InjuryJan 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSE FEMUR, CRUSHED MEDIAL FEMORAL CONDYLE AND CAVITARY DEFECT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21266067 ↗
• InjurySep 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 70 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, CONSTRAINED LINER REVISION, POLYETHYLENE LINER FRAGMENTATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20189287 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 95 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Synovitis

  MAUDE report 20090051 ↗
• InjuryFeb 7, 2024Unstable; Structural Problem; Naturally Worn; Unstable; Structural Problem; Naturally Worn

  IT WAS REPORTED THAT A 61 YO MALE PATIENT, INITIAL RIGHT TOTAL KNEE IMPLANTED IN 2016, DATE UNKNOWN, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE PATIENT BEGAN HAVING WORSENING RIGHT KNEE PAIN AND SWELLING APPROXIMATELY 1 YEAR AGO. AT FIRST IT SHOWED MORE SWELLING, HOWEVER OVER THE PAST 2-3 MONTHS THE PAIN SET IN. SWELLING ALSO OCCURRING. THE PATIENT SCHEDULED A FOLLOW UP WITH THE SURGEON AND WAS SEEN ON (B)(6) 2023. X-RAYS WERE OBTAINED WHICH WERE CONCERNING FOR MEDIAL POLYETHYLENE WEAR. GIVEN THE RADIOGRAPHIC EVIDENCE AS WELL AS THE PATIENT HAVING SWELLING AND INSTABILITY AND THE KNOWN RECALL WITH THE IMPLANT, THE PATIENT WAS SCHEDULED FOR A REVISION OF THE TIBIAL COMPONENT WITH A POLYETHYLENE EXCHANGE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND THE INCISION WAS MADE THROUGH THE EXISTING SCAR FROM THE PATIENT'S PRIMARY TKA. UPON MAKING THE ARTHROTOMY EXPOSURE AN EXCESSIVE AMOUNT OF JOINT FLUID CAME POURING OUT OF THE JOINT. THIS WAS AN EXCESS OF 450 ML. ONCE FURTHER EXPOSURE WAS MADE, EXTENSIVE SYNOVITIS WAS VISUALIZED. THE SURGEON MADE THE REMARK THAT THIS IS ONE OF THE WORST SYNOVIAL RESPONSES THAT HE IS EVER SEEN WITH THESE RECALL CASES. A MAJOR SYNOVECTOMY WAS

  Patient problems: Inflammation; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18662226 ↗
• InjuryJul 20, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON AN UNKNOWN DATE. 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. A FULL REVISION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE PATIENT UNDERWENT A TKA FULL REVISION TO A DIFFERENT COMPANY. THERE WAS A 45 MINUTE DELAY DUE TO NEEDING A FULL REVISION. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE.

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

  MAUDE report 17368270 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE 60 Y/O FEMALE PATIENT PRESENTED TO THE SURGEON¿S OFFICE IN 2019 WITH COMPLAINTS OF PAIN, SWELLING, AND INSTABILITY. AFTER EXAMINATION, THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TKA WITH A POSSIBLE POLY SWAP. DURING THAT SURGERY, THE POLY WAS REMOVED, AND THE PATIENT WAS REVISED TO A CRC SIZE 17MM POLY. THE SALES REP WAS UNABLE TO OBTAIN PHOTOS OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION; DISCARDED BY THE HOSPITAL. NO ADDITIONAL INFORMATION IS KNOWN TO THE SALES REP.

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

  MAUDE report 15718977 ↗

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