Optetrak Logic 02-012-47-5013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862174567), received between Sep 28, 2021 and Nov 30, 2023 — 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.

• InjuryNov 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 67 Y/O MALE PATIENT HAD A REVISION DUE TO DELAMINATION OF POLY INSERT. PATIENT'S LINER WAS EXCHANGED AND PATELLA WAS RESURFACED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Inflammation; Insufficient Information; Pain

  MAUDE report 18240427 ↗
• InjuryOct 26, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT IN 2015. APPROXIMATELY 8 YEARS 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: POLYETHYLENE WEAR OF LEFT KNEE JOINT PROSTHESIS. FINDINGS: THE COMPONENTS WERE IN EXCELLENT SHAPE. THE POLYETHYLENE WAS WEARING BOTH MEDIALLY AND LATERALLY. VERY THICKENED SYNOVIAL TISSUE AND FLUID.

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 18013552 ↗
• InjurySep 6, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL LEFT TKA, THIS 78 Y/O MALE PATIENT WAS REVISED DUE TO THE RECALL. THE POLY INSERT IN QUESTION IS INVOLVED IN THE RECALL. SURGEON EXPLANTED THE RECALLED POLY AND IMPLANTED A TRULIANT CR INSERT MATCHING THE EXPLANTED SIZE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING - REP IS UNABLE TO ACQUIRE FROM FACILITY. NO DEVICE IMAGES OR X-RAYS PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17690038 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY FIFTEEN MONTHS POST TKA, THE (B)(6) Y/O MALE PATIENT EXPERIENCED AN INFECTION. KNEE BECAME PAINFUL, RED AND SWOLLEN. FLUID DRAWN WAS POSITIVE FOR INFECTION. IRRIGATION AND DEBRIDEMENT DONE WITH TIBIAL INSERT REVISION. THE EVENT IS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE. DEVICE WILL NOT RETURN DUE TO STUDY POLICY. CARE IS NOTED AS CONTINUING.

  Patient problems: Bacterial Infection

  MAUDE report 12540255 ↗

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