Optetrak Logic 02-012-49-1513Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862144423), received between Jun 26, 2022 and Apr 16, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT POLY TIBIAL INSERT SWAP AND PATELLA SWAP AND WAS REVISED TO A TRULIANT CRC TIBIAL INSERT SZ 1.5 , 15MM SN: (B)(6) AND AN OPTETRAK 3 PEG PATELLA 29MM SN: (B)(6). THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO LAB AND LEGAL AT THE HOSPITAL. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

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

  MAUDE report 19122193 ↗
• InjuryMar 30, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; 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 WITH COMPLAINTS, INCLUDING PAIN AND DISSATISFACTION. THE PATIENT UNDERWENT A POLY SWAP ON (B)(6)2023 AND WAS REVISED TO A SIZE 15MM CRC POLY, SZ 1.5. PIECES OF POLY WERE REMOVED FROM THE PATIENT'S WOUND SITE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16643953 ↗
• InjuryJul 14, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED VIA A LEGAL FILING THAT A FEMALE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 3 YEARS 8 MONTHS POST HER INITIAL LEFT KNEE TKA. INITIALLY IMPLANTED WITH AN OPTETRAK DEVICE, INCLUDING A SIZE 1.5, 13 MM OPTETRAK LOGIC TIBIAL INSERTS MADE OF POLYETHYLENE. THE PLAINTIFF WAS DIAGNOSED WITH FAILED TOTAL ARTHROPLASTY WITH EARLY POLYETHYLENE FAILURE. BEFORE THE REVISION SURGERY, SHE WAS ALSO DIAGNOSED WITH OSTEOMYELITIS IN HER KNEE DUE TO THE BREAKDOWN OF THE POLYETHYLENE. DURING THE REVISION SURGERY, THE PLAINTIFF'S SURGEON STATED, "WE WERE ABLE TO LEVER THE POLYETHYLENE PLASTIC WITH A SMALL OSTEOTOME AND AFTER THIS WAS RETRIEVED, WE THEN INSPECTED THE PLASTIC, NOTED TO HAVE PITTING AND DELAMINATION OF THE MEDIAL ASPECT OF THE TIBIAL POLYETHYLENE. OTHERWISE, THE POLYETHYLENE LOOKED TO BE IN GOOD CONDITION LATERALLY."

  Patient problems: Osteomyelitis

  MAUDE report 15020156 ↗
• InjuryJun 26, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL BRIEF, PATIENT'S INITIAL TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2018. PATIENT'S UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 DUE TO PREMATURE FAILURE OF HIS EXACTECH OPTETRAK TOTAL KNEE DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Pain; Scar Tissue; Synovitis

  MAUDE report 14824552 ↗

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