Optetrak Logic 02-012-48-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862159304), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71 YO MALE PATIENT, INITIAL LEFT TOTAL KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS ON THEIR LEFT PRIMARY KNEE, INCLUDING PAIN AND DISSATISFACTION. IT WAS DETERMINED THE IMPLANTED POLY WAS PART OF THE RECALL. THE PATIENT UNDERWENT A POLY SWAP AND PATELLA SWAP. THE PATIENT WAS REVISED TO A SIZE 13MM CRC POLY FOR SZ 3.5 AND A 35MM ROUND 3 PEG CEMENTED PATELLA. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WAS RETURNED FOR ANALYSIS.

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

  MAUDE report 16668503 ↗

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