Optetrak Logic 02-012-47-5015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862174574), received between May 25, 2023 and Jan 22, 2024 — 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.

• InjuryJan 22, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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)2023. DIAGNOSIS: FAILED LEFT KNEE DUE TO POLYETHYLENE WEAR AND SEVERE FEMORAL TIBIAL OSTEOLYSIS THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. BOTH FEMORAL AND TIBIAL COMPONENTS APPEARED TO BY PARTIALLY DE BONDED DUE TO OSTEOLYSIS WITHIN THE SURROUNDING BONE. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 18550728 ↗
• InjuryMay 25, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN SURGICALLY REVISED ON (B)(6) 2022. THE REVISION SURGERY WAS APPROXIMATELY 5 YEARS, 8 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2022 /LEFT KNEE- ASEPTIC LOOSENING, REVISION OF ALL COMPONENTS. PATIENT HAD PROGRESSIVE/INCREASED PAIN AND SWELLING. RADIOGRAPHS SHOWED LOOSENING ABOUT THE FEMORAL COMPONENT. LAB STUDIES ARE NORMAL. FINDINGS: THE SYNOVIAL FLUID WAS CLEAR. THERE WAS AN ABUNDANT SYNOVIAL INFLAMMATION PRESENT. INSPECTION OF THE COMPONENTS SHOWED THAT THERE WAS EVIDENCE OF WEAR DEBRIS ON THE MEDIAL FEMUR POLYETHYLENE POSTEROMEDIALLY. THERE WAS OBVIOUS LOOSING OF THE FEMORAL COMPONENT. THE TIBIAL COMPONENT WAS SECURELY FIXED. THE PATELLA WAS IN APPROPRIATE POSITION. THE KNEE WAS STABLE AFTER REVISION. NO COMPLICATIONS DURING THE SURGICAL PROCEDURE. PROCEDURE: FEMORAL COMPONENT REMOVED; THERE WAS A MODERATE DEGREE OF BONE LOSS ON THE LATERAL CONDYLE, MINIMAL BONE LOSS ON THE MEDIAL CONDYLE WITH EXTENSIVE RESORPTION FROM POLYETHYLENE PARTICLE REACTION. TIBIAL COMPONENT SECURELY FIXED AND WAS REMOVED WITH MODEST BONE LOSS. OCCLUSIVE DRESS

  Patient problems: Implant Pain; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17007997 ↗

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