Optetrak Logic 02-012-48-5011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862174598), received between Feb 20, 2023 and Jun 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 61 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO EFFUSION AND DISCOMFORT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED LEFT KNEE WITH POLYETHYLENE WEAR THERE WAS NO METALLOSIS OR PURULENCE PRESENT WITH THE SYNOVIAL FLUID AND NO EVIDENCE OF IMPINGEMENT OF THE METALLIC IMPLANT CEMENT AND THE METALLIC IMPLANTS WERE DEEMED COMPETENT. THE PATIENT WAS AWOKEN AND TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS OCCURRED THROUGHOUT THE CASE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 17096815 ↗
• InjuryFeb 20, 2023Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  ADDITIONAL INFORMATION - LEFT TOTAL KNEE ARTHROPLASTY REVISION FOR POLY SWAP. APPROXIMATELY 6 YEARS AFTER IMPLANT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN, HOSPITAL RETAINED. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Failure of Implant; Inflammation; Joint Laxity; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 16406238 ↗

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