Optetrak Logic 02-012-49-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862144409), received between Jun 19, 2020 and May 1, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2024Naturally Worn; Naturally Worn

  AS REPORTED, SIX YEARS AFTER THE INITIAL LEFT THA SURGERY, THE 64 YEAR OLD FEMALE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND A REVISION WAS PERFORMED ON AN UNKNOWN DATE. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. NO METALLOSIS WAS FOUND. THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY. ALL PROLIFERATIVE TISSUE WAS REMOVED AND ONLY THE TIBIAL INSERT WAS REPLACED. ALL PARTS/PIECES WERE REMOVED FROM THE PATIENT. 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; Pain; Swelling/ Edema

  MAUDE report 19219940 ↗
• InjuryJul 17, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE REVISION WAS DUE TO POLY WEAR. THE LINER WAS EXCHANGED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT HISTORY, X-RAYS, OR DEVICE IMAGES WERE PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. THE HOSPITAL DISPOSED OF THE DEVICE. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 17333907 ↗
• InjuryJun 19, 2020Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2 YEARS AND 8 MONTHS POSTOP THE INITIAL IMPLANT, THE (B)(6) Y/O FEMALE PATIENT, PREVIOUSLY TREATED FOR RIGHT KNEE WINDSWEPT DEFORMITY, HAD SEVERE RIGHT KNEE PAIN, THEN A PATELLOFEMORAL ARTHROSIS WAS SUSPECTED BY THE X-RAY FINDINGS. THE SURGEON PREFERS THE SURGICAL PHILOSOPHY WITHOUT RESURFACING PATELLA FOR PRIMARY KNEE REPLACEMENT SURGERY AND HE HAS EXCELLENT LONG-TERM CLINICAL RESULTS FOR THIS PHILOSOPHY, HOWEVER, HE PLANNED TO RESURFACE THE PATELLA USING OUR PATELLA COMPONENT FOR THIS CASE. WHEN THE KNEE WAS EXPOSED, ABNORMAL PROLIFERATIVE SYNOVIUM WAS SEEN AROUND THE KNEE, AND REMARKABLE POLYETHYLENE WEAR OF THE TIBIAL INSERT WAS ALSO FOUND AT THE ANTERO-LATERAL PART OF THE INSERT. THEN HE REMOVED THE INSERT TO CHECK THE CONDITION OF POSTERIOR ASPECT OF THE KNEE, HE CONFIRMED THAT POSTER-MEDICAL PART OF THE INSERT WAS SEVERELY DAMAGED BY DELAMINATION WEAR. AS HE WAS CONCERNED ABOUT USING SAME TYPE TO THE SLOPED INSERT, HE PERFORMED TRIAL REDUCTION USING THE NEUTRAL INSERT OF 9 MM THICKNESS AND DECIDED TO USE IT FOR THIS REPLACEMENT. HE ALSO ADDED V-SHAPE ARTHROTOMY TO ADDRESS THE JOINT STIFFNESS IN FLEXION. THE SURGERY WAS FINISHED INSERTING THE NEUTRA

  Patient problems: Failure of Implant

  MAUDE report 10177026 ↗

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